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Unhealthy Moves by the FTC and Stop Saying Maybe on MAbs - TPA Weekly Update: April 19, 2024
| From | David Williams <[email protected]> |
| Subject | Unhealthy Moves by the FTC and Stop Saying Maybe on MAbs - TPA Weekly Update: April 19, 2024 |
| Date | April 19, 2024 8:00 PM |
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Unhealthy Moves by the FTC
The current Federal Trade Commission (FTC) has dedicated itself to indulging the obsessions and idiosyncrasies of a certain type of technocratic progressive instead of consumers’ interests. As detailed in a recent House Judiciary Committee report, the agency leadership’s bid to remake American antitrust law has become mired in its own administrative incompetence and ideologically blinkered aggression. One FTC staffer reported that often, FTC leadership’s “stated objectives sound more like progressive buzzwords than actual direction.” Staffers also said that (in the committee’s words) “direction from senior leadership on specific cases amounted to nothing more than telling staff to bring a case, even if the case was unwarranted.” The FTC has now turned its sights on private equity’s role in healthcare. Chair Lina Khan has long distrusted relationships between private equity and healthcare. In September, the agency threw basic corporate law principles to the wind, suing private equity firm
Welsh Carson Anderson & Stowe, over the acquisition practices in Texas of U.S. Anesthesia Partners, a company in which Welsh Carson held a minority investment. In March, Khan announced a joint probe with the Department of Justice to examine the nexus as well as “corporate profiteering in health care” per se.
The FTC has not even attempted to hide its biases. At a March public workshop on private equity and healthcare, the agency convened a panel of uniformly skeptical experts, a bias highlighted by the American Investment Council (AIC). But, as AIC flagged last week, the FTC subsequently held “a more balanced, research-driven closed-door briefing,” whose findings and conclusions the agency refuses to make public. Economists at this second event disputed the FTC’s assumptions, the AIC says. However, the agency saw fit for public consumption only those expert opinions that confirmed its biases. To be sure, private equity acquisitions (like any other category of acquisition), may violate antitrust law. Such deals may in some cases lead to consumer harms, and businesspeople involved may in some cases make dubious judgements, leading to post-acquisition debacles. None of this, however, pertains uniquely to private equity — or to the healthcare industry. Likewise, the slew of healthcare facilities
that have floundered in the wake of private equity acquisitions (the primary evidence in the progressive case against private equity) reflect larger industry dynamics — not fund managers’ unique perfidy. Staff downsizing and facility closers plague facilities with many ownership models, including nonprofits. The myopic mythmaking surrounding private equity’s role in an otherwise troubled industry renders thoughtful analysis impossible.
The progressive narrative also ignores private equity’s tremendous healthcare investments. By siphoning capital from those who have too much to those in need of it — a necessary task in any advanced economy — private equity makes available goods and services that otherwise could not reach market. This is, in the healthcare industry, often a literal matter of life and death. Private equity’s investments in the sector exceed $70 billion, according to a recent report. This amount includes billions of dollars supporting facilities in perennially healthcare-challenged rural America. Subjecting any industry to regulatory burdens disincentivizes participation in it. The right kind of scrutiny, which pursues a legitimate government interest with means grounded in sound economics, keeps markets operational. The product of such scrutiny (well-functioning markets, free of grift and abuse) justifies the attendant regulatory costs many times over. But the FTC is engaged in something else entirely: It
has deployed dubious economics to further a grudge against a disfavored industry. For taxpayers, this means federal funds siphoned to the FTC’s sensationalist scapegoating. For many patients — especially for those in rural areas, with poor and or sparse care options — the FTC’s crusade will likely end in worse healthcare as risk-averse private-equity funds scoot away from the industry. Economists cannot fully quantify such costs.
It is impossible to determine how many struggling hospitals FTC overreach will dissuade funds from saving with a cash infusion. This fact will do nothing for patients who, absent the agency’s ideological fever, could have gained access to new, or higher quality, private-equity-backed medical facilities.
Stop Saying “Maybe” on MAbs
It’s tempting to think of COVID-19 as an afterthought and relic of the 2020-2021 period. But, to millions of vulnerable Americans with weak immune systems, the disease/virus is still a real and scary prospect. Help is on the way, thanks to a type of monoclonal antibody (mAb) infusion called Pemgarda, which was recently approved by the Food and Drug Administration (FDA) for emergency use authorization (EUA). The infusion is designed to be taken multiple times per year for patients who are not likely to mount an adequate immune response to COVID-19 even after getting their shots. While the FDA should be applauded for their EUA, the agency must do far more to ensure that monoclonal antibody treatments are available for patients who need them the most. Restrictive regulatory policies will fail patients and cost lives in the war against the deadly disease. Newly available treatments such as Pemgarda will help immunocompromised patients left behind in the “post-pandemic” era. According to Yale
Medicine infectious diseases specialist Dr. Scott Roberts, the “population identified as moderately to severely immunocompromised includes solid organ transplant recipients, stem cell transplant recipients, and those who are on chemotherapy for cancers such as lymphoma and leukemia, among many others. This group is also less likely to build enough protection against COVID after vaccination. Hopefully, this new treatment will help the vulnerable feel safer.” Manufactured proteins such as Pemgarda work wonders by targeting specific viruses or cancer cells and attaching themselves to them. Once these “designer antibodies” are bound to their targets, the virus is neutralized, and the body’s own immune system is flagged to finish the job. The problem is that COVID-19 has constantly changed over the past three years, and older mAbs are not as effective in dealing with newer coronavirus variants, not unlike the vaccines.
The FDA’s recent authorization of Pemgarda seems to mark a regulatory reversal, but unfortunately, doctors, patients, and manufacturers have little insight into the approval process. The FDA’s approval process for these treatments is a black box and requires critical time and resources that patients and innovators do not have. The lack of monoclonal antibody products on the market has created a dire situation for millions of patients with preexisting conditions, who must now risk dangerous drug interactions if they have the misfortune of contracting the coronavirus. While one approved and available drug will undoubtedly improve matters, any supply disruption or significant virus mutations will mean that patients must once again go without COVID-19 treatments. It does not have to be this way. For example, the FDA currently approves updated versions of the flu vaccine quickly and without the need for expansive clinical trials. All that is typically needed are studies involving 300 adults to
ensure effectiveness. The time from identification of new strains to FDA approval is four months, ensuring that patients have reliable access to the latest vaccine version by flu season.
Instead of allowing for quick, flexible trials, the FDA is asking mAb producers for product demand plans, manufacturing scale-up plans, raw materials shortage contingencies “well...in advance” of development. Meanwhile, patient demand is not being met and products are not scaling up because there are so few approved products on the market. It is time for the FDA to reverse course and define a clear process to get life-saving monoclonal antibodies on the market on a continual basis. This will allow our nation to be more proactive in the fight against COVID-19 versus being too slow to react to the quickly changing virus. Millions of lives depend on a faster, more flexible approach.
Blogs:
Monday: Tax Day 2024: Taxpayer Watchdog Warns of IRS Incompetence, Problematic Direct File ([link removed])
Tuesday: TPA Testifies Against Colorado’s Right to Repair Legislation ([link removed])
Wednesday: Elon Musk’s ‘Community Notes’ are Exposing the WHO’s Lies ([link removed])
Thursday: Biden’s Student Loan Cancellation Policies Are More Likely to Increase Student Debt ([link removed])
Friday: TPA Weighs In On Key Congressional Hearings ([link removed])
Media:
April 4, 2024: The Colorado Springs Gazette (Colorado Springs, Co.) mentioned TPA in the op-ed, “Biden administration antitrust efforts aim to take bite out of Apple.”
April 4, 2024: WJLA ABC7 (Washington, D.C.) quoted TPA in their story, “Controversial budget bill proposes hefty auto-related tax and fee hikes in Maryland.
April 4, 2024: Townhall ran TPA’s op-ed, “FDA Ending Not-So-Sweet Cherry Pie Regulations."
April 5, 2024: The Denver Gazette (Denver, Co.) mentioned TPA in the op-ed, “Biden administration antitrust efforts aim to take bite out of Apple.”
April 5, 2024: I appeared on 55KRC Radio (Cincinnati, Ohio) to talk about net neutrality and our Bill of the Month.
April 5, 2024: Android News mentioned TPA in their article, “Meta insists acquiring Instagram and WhatsApp wasn't monopolistic.”
April 5, 2024: Real Clear Markets ran TPA’s op-ed, “The FTC’s Investigation of Reddit Underscores a Scattered, Wrathful Khan."
April 6, 2024: The Daily News (Bowling Green, Ky.) mentioned TPA in their article, “Energy bill needs to be vetoed.”
April 8, 2024: The Federalist mentioned TPA in their auricle, “CDC, FDA Want Millions Of Taxpayer Dollars To Keep Fomenting Nicotine Misinformation Campaigns.”
April 8, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about tax increases in Maryland.
April 9, 2024: The Blaze ran TPA’s op-ed, “Elon Musk’s ‘Community Notes’ are exposing the WHO’s lies.”
April 10, 2024: Issues & Insights ran TPA’s op-ed, “Regulatory Reform Can Pry Plaque From Americans’ Arteries.”
April 10, 2024: Catalyst ran TPA’s op-ed, “FCC’s New Broadband Standard Could Impact Fiber Alternatives."
April 11, 2024: I appeared on NewsTalk STL 101.9 FM (St. Louis, Mo.) to talk about Tax Day.
April 11, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about the PORT Act.
April 11, 2024: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about inflation and deficit spending.
April 11, 2024: Inside Sources ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Charlotte Observer ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Rock Hill Herald (Rock Hill, SC) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: Arca Max ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Fresno Bee (Fresno, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Centre Daily Times (Bellefonte, Pa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Bradenton Herald (Bradenton, Fla.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Merced Sun-Star (Merced, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Modesto Bee (Modesto, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Tri-City Herald Online (Kennewick, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Island Packet (Bluffton, S.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Ledger-Examiner (Columbus, Ga.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Idaho Statesman (Boise, Idaho) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Myrtle Beach Sun News (Myrtle Beach, S.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Durham Herald Sun (Durham, N.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Bellingham Herald (Bellingham, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Tacoma News Tribune (Tacoma, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Olympian (Olympia, Wash.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Belleville News Democrat (Belleville, Ill.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: KansasCity.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Sun Herald (Gulfport, Miss.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Macon Telegraph (Macon, Ga.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: SanLuisObispo.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Star-Telegram (Fort Worth, Texas) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: Inside Sources ran TPA’s op-ed, “FDA Finally Realizes that Yogurt Is Healthy.”
April 11, 2024: The Daily Caller ran TPA’s op-ed, “Biden’s Student Loan Cancellation Policies Are More Likely To Harm Than Help.”
April 11, 2024: The South Carolina State (Columbia, S.C.) “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.“
April 11, 2024: CPA Technology Advisor ran TPA’s op-ed, ““Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 12, 2024: I appeared on the Doug Wagner Show on Newsradio 600 WMT (Waterloo, Iowa) to talk about Tax Day.
April 12, 2024: ValleyNewsToday.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 12, 2024: The Wahoo Newspaper (Wahoo, NE) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Lake Geneva Regional News (Lake Geneva, Wisconsin.) “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Chippewa Falls Online (Chippewa Falls, Wisc.) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: The Bismarck Tribune (Bismarck, ND) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Newsday mentioned TPA in their article, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The Hampton Roads Daily Press (Newport News, Va.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: Patrick Hedger appeared on Fox 5 DC (Washington, DC) to talk about Tax Day and Direct File.
April 12, 2024: The Orangeburg Teems and Democrat (Orangeburg, S.C.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: DBRNews.com ([link removed]) ran TAP’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The North Platte Telegraph (North Platte, Nebraska.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The Buffalo News (Buffalo, N.Y.) ran TPA’s op-ed, “Don’t trust the iRS to do your taxes.”
April 12, 2024: The Baltimore Post (Baltimore, Md.) quoted tPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 2024: Regional Media News (Blue Grass, Iowa) quoted TPA in their story, ““Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 2024: Fox Business interviewed Dan Savickas in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 13, 2024: Vaping Post mentioned TPA is their article, “The U.S. FDA And CDC Want More Funding to Finance Their Anti-THR Campaigns.”
April 13, 2024: The Pittsburgh Tribune Review (Pittsburgh, Pa.) ran TPA’s op-ed, “Counterpoint: IRS shouldn’t be trusted with Direct File.”
April 13, 2024: The Boston Herald (Boston, Mass.) ran TPA’s op-ed, “Consumer choice; FDA takes years to decide yogurt is healthy.”
April 13, 2024: The Herald Bulletin (New Britain, Conn.) ran TPA’s op-ed, “The FDA finally realizes that yogurt is healthful food; Opinion.”
April 13, 2024: The Bristol Press (Bristol, Conn.) ran TPA’s op-ed, “The FDA finally realizes that yogurt is healthful food; Opinion.”
April 13, 2024: The Virginian-Pilot (Norfolk, Va.) ran TPA’s op-ed, “Do not trust IRS Direct File.”
April 13, 2024: The Chronicle (Willmantic, Conn.) ran TPA’s op-ed, “The FD A finally realizes that yogurt is healthful food; Opinions.”
April 14, 2024: KFXZ-AM (Lafayette, La.) mentioned TPOA in their story about Tax Day.
April 14, 2024: KSSZ-FM (Columbia, Mo.) mentioned TPA in their story about Tax Day.
April 14, 2024: KVOI-AM (Tucson, Ariz.) mentioned TPA in their story about Tax Day.
April 14, 2024: The Lincoln Journal Star (Lincoln, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 14, 2024: WSBA-AM (Harrisburg, Pa,) mentioned TPOA in their story about Tax Day.
April 15, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about Tax Day and the new Direct File Program
April 15, 2024: AOL.com ([link removed]) quoted TPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 0224: Yahoo Finance quoted TPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 15, 2024: I appeared on KNUS 710 AM radio (Denver, Col.) to talk about Tax Day.
April 15, 2024: WBFF Fox45 (Baltimore, Md.) quoted TPA in their story, “Maryland is investing billions into education, why are schools cutting jobs and programs?”
April 15, 2024: Patrick Hedger appeared on Memphis Morning News (NewsTalk 98.9) to discuss Tax Day
April 15, 2024: Real America’s Voice quoted TPA in their story, “Two Big Problems with IRS Direct File.”
April 15, 2024: Patrick Hedger appeared on the Ross Kaminsky Show (Denver, Col.) to discuss Tax Day and Direct File.
April 15, 2024: KOA 850 AM (Denver, Col.) quoted TPA in their story, “It's Tax Day with Patrick Hedger of the Taxpayers Protection Alliance.”
April 15, 2024: Patrick Hedger appeared on “Always Right Radio” with Bob Frantz (Cleveland, Ohio) to discuss Tax Day, Direct File, and tax reform.
April 15, 2024: KHOW 630 AM quoted TPA in their story, “Tax Day with Patrick Hedger of the Taxpayers Protection Alliance.”
April 15, 2024: The Dispatch-Argus (Moline, IL) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: Es de Latino News ran TPA’s op-ed, “Contrapunto: No se debe confiar al IRS Direct File.”
April 15, 2024: The Orlando Sentinel (Orlando, Fla.) ran TPA’s op-ed, “IRS shouldn't be trusted with Direct File.”
April 15, 2024: The Tribune-Review (Pittsburgh, Pa.) ran TPA’s op-ed, “IRS shouldn't be trusted with Direct File system.”
April 15, 2024: Just the News interviewed Patrick Hedger about Tax Day and Direct File.
April 15, 2024: The Richmond Times-Dispatch (Richmond, Va.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: The News & Advance (Lynchburg, Va.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: The Quad-City Times (Davenport, Iowa) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: Dan Savickas appeared on the Schilling Show (Charlottesville, Va.) to discuss Tax Day and Direct File.
April 15, 2024: Patrick Hedger appeared on Real America’s Voice to discuss Tax Day and Direct File.
April 16, 2024: Townhall.com ([link removed]) ran TPA’s op-ed, “Democrats Should Join the Call for FDA to Accelerate Approval of Smokefree Products.”
April 16, 2024: Real Clear Health ran TPA’s op-ed, “FDA Needs to Stop Saying 'Maybe' on mAbs.”
April 16, 2024: The Kearney Hub (Kearney, Neb.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Davis Enterprise (Davis, Calif.) ran TPA’s op-ed, “FDA finally realizes that yogurt is healthful.”
April 16, 2024: Tulsa World (Tulsa, Okla.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Martinsville Bulletin (Martinsville, Va.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Morning News (Johnsonville, S.C.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Press of Atlantic City (Atlantic City, N.J.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: American Family News quoted TPA in their story, “Gov't giving green light to make problem worse.”
April 16, 2024: The Hickory Daily Record (Hickory, N.C.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Journal Times (Racine, Wise.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Grand Island Independent (Grand Island, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Kenosha News (Kenosha, Wisconsin.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: Inside EPA mentioned TPA in their story, “Host Of Industry Groups Press EPA To Reject California Locomotive Waiver.”
April 17, 2024: The York News-Times (York, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 17, 2024: The Herald & Review (Decatur, Il.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 17, 2024: The Pantagraph (Bloomington, Il.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 18, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about polling about the Kirwan Commission.
April 18, 2024: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about tariffs and antitrust.
April 18, 2024: Real Clear Markets ran TPA’s op-ed, “The FTC's Unhealthy Obsession With Private Equity.”
Have a great weekend!
Best,
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 1120
Washington, D.C. xxxxxx
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The current Federal Trade Commission (FTC) has dedicated itself to indulging the obsessions and idiosyncrasies of a certain type of technocratic progressive instead of consumers’ interests. As detailed in a recent House Judiciary Committee report, the agency leadership’s bid to remake American antitrust law has become mired in its own administrative incompetence and ideologically blinkered aggression. One FTC staffer reported that often, FTC leadership’s “stated objectives sound more like progressive buzzwords than actual direction.” Staffers also said that (in the committee’s words) “direction from senior leadership on specific cases amounted to nothing more than telling staff to bring a case, even if the case was unwarranted.” The FTC has now turned its sights on private equity’s role in healthcare. Chair Lina Khan has long distrusted relationships between private equity and healthcare. In September, the agency threw basic corporate law principles to the wind, suing private equity firm
Welsh Carson Anderson & Stowe, over the acquisition practices in Texas of U.S. Anesthesia Partners, a company in which Welsh Carson held a minority investment. In March, Khan announced a joint probe with the Department of Justice to examine the nexus as well as “corporate profiteering in health care” per se.
The FTC has not even attempted to hide its biases. At a March public workshop on private equity and healthcare, the agency convened a panel of uniformly skeptical experts, a bias highlighted by the American Investment Council (AIC). But, as AIC flagged last week, the FTC subsequently held “a more balanced, research-driven closed-door briefing,” whose findings and conclusions the agency refuses to make public. Economists at this second event disputed the FTC’s assumptions, the AIC says. However, the agency saw fit for public consumption only those expert opinions that confirmed its biases. To be sure, private equity acquisitions (like any other category of acquisition), may violate antitrust law. Such deals may in some cases lead to consumer harms, and businesspeople involved may in some cases make dubious judgements, leading to post-acquisition debacles. None of this, however, pertains uniquely to private equity — or to the healthcare industry. Likewise, the slew of healthcare facilities
that have floundered in the wake of private equity acquisitions (the primary evidence in the progressive case against private equity) reflect larger industry dynamics — not fund managers’ unique perfidy. Staff downsizing and facility closers plague facilities with many ownership models, including nonprofits. The myopic mythmaking surrounding private equity’s role in an otherwise troubled industry renders thoughtful analysis impossible.
The progressive narrative also ignores private equity’s tremendous healthcare investments. By siphoning capital from those who have too much to those in need of it — a necessary task in any advanced economy — private equity makes available goods and services that otherwise could not reach market. This is, in the healthcare industry, often a literal matter of life and death. Private equity’s investments in the sector exceed $70 billion, according to a recent report. This amount includes billions of dollars supporting facilities in perennially healthcare-challenged rural America. Subjecting any industry to regulatory burdens disincentivizes participation in it. The right kind of scrutiny, which pursues a legitimate government interest with means grounded in sound economics, keeps markets operational. The product of such scrutiny (well-functioning markets, free of grift and abuse) justifies the attendant regulatory costs many times over. But the FTC is engaged in something else entirely: It
has deployed dubious economics to further a grudge against a disfavored industry. For taxpayers, this means federal funds siphoned to the FTC’s sensationalist scapegoating. For many patients — especially for those in rural areas, with poor and or sparse care options — the FTC’s crusade will likely end in worse healthcare as risk-averse private-equity funds scoot away from the industry. Economists cannot fully quantify such costs.
It is impossible to determine how many struggling hospitals FTC overreach will dissuade funds from saving with a cash infusion. This fact will do nothing for patients who, absent the agency’s ideological fever, could have gained access to new, or higher quality, private-equity-backed medical facilities.
Stop Saying “Maybe” on MAbs
It’s tempting to think of COVID-19 as an afterthought and relic of the 2020-2021 period. But, to millions of vulnerable Americans with weak immune systems, the disease/virus is still a real and scary prospect. Help is on the way, thanks to a type of monoclonal antibody (mAb) infusion called Pemgarda, which was recently approved by the Food and Drug Administration (FDA) for emergency use authorization (EUA). The infusion is designed to be taken multiple times per year for patients who are not likely to mount an adequate immune response to COVID-19 even after getting their shots. While the FDA should be applauded for their EUA, the agency must do far more to ensure that monoclonal antibody treatments are available for patients who need them the most. Restrictive regulatory policies will fail patients and cost lives in the war against the deadly disease. Newly available treatments such as Pemgarda will help immunocompromised patients left behind in the “post-pandemic” era. According to Yale
Medicine infectious diseases specialist Dr. Scott Roberts, the “population identified as moderately to severely immunocompromised includes solid organ transplant recipients, stem cell transplant recipients, and those who are on chemotherapy for cancers such as lymphoma and leukemia, among many others. This group is also less likely to build enough protection against COVID after vaccination. Hopefully, this new treatment will help the vulnerable feel safer.” Manufactured proteins such as Pemgarda work wonders by targeting specific viruses or cancer cells and attaching themselves to them. Once these “designer antibodies” are bound to their targets, the virus is neutralized, and the body’s own immune system is flagged to finish the job. The problem is that COVID-19 has constantly changed over the past three years, and older mAbs are not as effective in dealing with newer coronavirus variants, not unlike the vaccines.
The FDA’s recent authorization of Pemgarda seems to mark a regulatory reversal, but unfortunately, doctors, patients, and manufacturers have little insight into the approval process. The FDA’s approval process for these treatments is a black box and requires critical time and resources that patients and innovators do not have. The lack of monoclonal antibody products on the market has created a dire situation for millions of patients with preexisting conditions, who must now risk dangerous drug interactions if they have the misfortune of contracting the coronavirus. While one approved and available drug will undoubtedly improve matters, any supply disruption or significant virus mutations will mean that patients must once again go without COVID-19 treatments. It does not have to be this way. For example, the FDA currently approves updated versions of the flu vaccine quickly and without the need for expansive clinical trials. All that is typically needed are studies involving 300 adults to
ensure effectiveness. The time from identification of new strains to FDA approval is four months, ensuring that patients have reliable access to the latest vaccine version by flu season.
Instead of allowing for quick, flexible trials, the FDA is asking mAb producers for product demand plans, manufacturing scale-up plans, raw materials shortage contingencies “well...in advance” of development. Meanwhile, patient demand is not being met and products are not scaling up because there are so few approved products on the market. It is time for the FDA to reverse course and define a clear process to get life-saving monoclonal antibodies on the market on a continual basis. This will allow our nation to be more proactive in the fight against COVID-19 versus being too slow to react to the quickly changing virus. Millions of lives depend on a faster, more flexible approach.
Blogs:
Monday: Tax Day 2024: Taxpayer Watchdog Warns of IRS Incompetence, Problematic Direct File ([link removed])
Tuesday: TPA Testifies Against Colorado’s Right to Repair Legislation ([link removed])
Wednesday: Elon Musk’s ‘Community Notes’ are Exposing the WHO’s Lies ([link removed])
Thursday: Biden’s Student Loan Cancellation Policies Are More Likely to Increase Student Debt ([link removed])
Friday: TPA Weighs In On Key Congressional Hearings ([link removed])
Media:
April 4, 2024: The Colorado Springs Gazette (Colorado Springs, Co.) mentioned TPA in the op-ed, “Biden administration antitrust efforts aim to take bite out of Apple.”
April 4, 2024: WJLA ABC7 (Washington, D.C.) quoted TPA in their story, “Controversial budget bill proposes hefty auto-related tax and fee hikes in Maryland.
April 4, 2024: Townhall ran TPA’s op-ed, “FDA Ending Not-So-Sweet Cherry Pie Regulations."
April 5, 2024: The Denver Gazette (Denver, Co.) mentioned TPA in the op-ed, “Biden administration antitrust efforts aim to take bite out of Apple.”
April 5, 2024: I appeared on 55KRC Radio (Cincinnati, Ohio) to talk about net neutrality and our Bill of the Month.
April 5, 2024: Android News mentioned TPA in their article, “Meta insists acquiring Instagram and WhatsApp wasn't monopolistic.”
April 5, 2024: Real Clear Markets ran TPA’s op-ed, “The FTC’s Investigation of Reddit Underscores a Scattered, Wrathful Khan."
April 6, 2024: The Daily News (Bowling Green, Ky.) mentioned TPA in their article, “Energy bill needs to be vetoed.”
April 8, 2024: The Federalist mentioned TPA in their auricle, “CDC, FDA Want Millions Of Taxpayer Dollars To Keep Fomenting Nicotine Misinformation Campaigns.”
April 8, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about tax increases in Maryland.
April 9, 2024: The Blaze ran TPA’s op-ed, “Elon Musk’s ‘Community Notes’ are exposing the WHO’s lies.”
April 10, 2024: Issues & Insights ran TPA’s op-ed, “Regulatory Reform Can Pry Plaque From Americans’ Arteries.”
April 10, 2024: Catalyst ran TPA’s op-ed, “FCC’s New Broadband Standard Could Impact Fiber Alternatives."
April 11, 2024: I appeared on NewsTalk STL 101.9 FM (St. Louis, Mo.) to talk about Tax Day.
April 11, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about the PORT Act.
April 11, 2024: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about inflation and deficit spending.
April 11, 2024: Inside Sources ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Charlotte Observer ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Rock Hill Herald (Rock Hill, SC) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: Arca Max ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Fresno Bee (Fresno, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Centre Daily Times (Bellefonte, Pa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Bradenton Herald (Bradenton, Fla.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Merced Sun-Star (Merced, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Modesto Bee (Modesto, Calif.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Tri-City Herald Online (Kennewick, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Island Packet (Bluffton, S.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Ledger-Examiner (Columbus, Ga.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Idaho Statesman (Boise, Idaho) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Myrtle Beach Sun News (Myrtle Beach, S.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Durham Herald Sun (Durham, N.C.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Bellingham Herald (Bellingham, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Tacoma News Tribune (Tacoma, Wa.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Olympian (Olympia, Wash.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Belleville News Democrat (Belleville, Ill.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: KansasCity.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Sun Herald (Gulfport, Miss.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Macon Telegraph (Macon, Ga.) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: SanLuisObispo.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: The Star-Telegram (Fort Worth, Texas) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 11, 2024: Inside Sources ran TPA’s op-ed, “FDA Finally Realizes that Yogurt Is Healthy.”
April 11, 2024: The Daily Caller ran TPA’s op-ed, “Biden’s Student Loan Cancellation Policies Are More Likely To Harm Than Help.”
April 11, 2024: The South Carolina State (Columbia, S.C.) “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.“
April 11, 2024: CPA Technology Advisor ran TPA’s op-ed, ““Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 12, 2024: I appeared on the Doug Wagner Show on Newsradio 600 WMT (Waterloo, Iowa) to talk about Tax Day.
April 12, 2024: ValleyNewsToday.com ([link removed]) ran TPA’s op-ed, “Counterpoint: IRS Shouldn’t Be Trusted With Direct File.”
April 12, 2024: The Wahoo Newspaper (Wahoo, NE) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Lake Geneva Regional News (Lake Geneva, Wisconsin.) “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Chippewa Falls Online (Chippewa Falls, Wisc.) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: The Bismarck Tribune (Bismarck, ND) ran TPA’s op-ed, “Don’t Trust the IRS to do your taxes.”
April 12, 2024: Newsday mentioned TPA in their article, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The Hampton Roads Daily Press (Newport News, Va.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: Patrick Hedger appeared on Fox 5 DC (Washington, DC) to talk about Tax Day and Direct File.
April 12, 2024: The Orangeburg Teems and Democrat (Orangeburg, S.C.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: DBRNews.com ([link removed]) ran TAP’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The North Platte Telegraph (North Platte, Nebraska.) ran TPA’s op-ed, “IRS shouldn’t be trusted with Direct File.”
April 12, 2024: The Buffalo News (Buffalo, N.Y.) ran TPA’s op-ed, “Don’t trust the iRS to do your taxes.”
April 12, 2024: The Baltimore Post (Baltimore, Md.) quoted tPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 2024: Regional Media News (Blue Grass, Iowa) quoted TPA in their story, ““Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 2024: Fox Business interviewed Dan Savickas in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 13, 2024: Vaping Post mentioned TPA is their article, “The U.S. FDA And CDC Want More Funding to Finance Their Anti-THR Campaigns.”
April 13, 2024: The Pittsburgh Tribune Review (Pittsburgh, Pa.) ran TPA’s op-ed, “Counterpoint: IRS shouldn’t be trusted with Direct File.”
April 13, 2024: The Boston Herald (Boston, Mass.) ran TPA’s op-ed, “Consumer choice; FDA takes years to decide yogurt is healthy.”
April 13, 2024: The Herald Bulletin (New Britain, Conn.) ran TPA’s op-ed, “The FDA finally realizes that yogurt is healthful food; Opinion.”
April 13, 2024: The Bristol Press (Bristol, Conn.) ran TPA’s op-ed, “The FDA finally realizes that yogurt is healthful food; Opinion.”
April 13, 2024: The Virginian-Pilot (Norfolk, Va.) ran TPA’s op-ed, “Do not trust IRS Direct File.”
April 13, 2024: The Chronicle (Willmantic, Conn.) ran TPA’s op-ed, “The FD A finally realizes that yogurt is healthful food; Opinions.”
April 14, 2024: KFXZ-AM (Lafayette, La.) mentioned TPOA in their story about Tax Day.
April 14, 2024: KSSZ-FM (Columbia, Mo.) mentioned TPA in their story about Tax Day.
April 14, 2024: KVOI-AM (Tucson, Ariz.) mentioned TPA in their story about Tax Day.
April 14, 2024: The Lincoln Journal Star (Lincoln, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 14, 2024: WSBA-AM (Harrisburg, Pa,) mentioned TPOA in their story about Tax Day.
April 15, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about Tax Day and the new Direct File Program
April 15, 2024: AOL.com ([link removed]) quoted TPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 12, 0224: Yahoo Finance quoted TPA in their story, “Economists weigh pros and cons of Trump plan for 60% tariff on China.”
April 15, 2024: I appeared on KNUS 710 AM radio (Denver, Col.) to talk about Tax Day.
April 15, 2024: WBFF Fox45 (Baltimore, Md.) quoted TPA in their story, “Maryland is investing billions into education, why are schools cutting jobs and programs?”
April 15, 2024: Patrick Hedger appeared on Memphis Morning News (NewsTalk 98.9) to discuss Tax Day
April 15, 2024: Real America’s Voice quoted TPA in their story, “Two Big Problems with IRS Direct File.”
April 15, 2024: Patrick Hedger appeared on the Ross Kaminsky Show (Denver, Col.) to discuss Tax Day and Direct File.
April 15, 2024: KOA 850 AM (Denver, Col.) quoted TPA in their story, “It's Tax Day with Patrick Hedger of the Taxpayers Protection Alliance.”
April 15, 2024: Patrick Hedger appeared on “Always Right Radio” with Bob Frantz (Cleveland, Ohio) to discuss Tax Day, Direct File, and tax reform.
April 15, 2024: KHOW 630 AM quoted TPA in their story, “Tax Day with Patrick Hedger of the Taxpayers Protection Alliance.”
April 15, 2024: The Dispatch-Argus (Moline, IL) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: Es de Latino News ran TPA’s op-ed, “Contrapunto: No se debe confiar al IRS Direct File.”
April 15, 2024: The Orlando Sentinel (Orlando, Fla.) ran TPA’s op-ed, “IRS shouldn't be trusted with Direct File.”
April 15, 2024: The Tribune-Review (Pittsburgh, Pa.) ran TPA’s op-ed, “IRS shouldn't be trusted with Direct File system.”
April 15, 2024: Just the News interviewed Patrick Hedger about Tax Day and Direct File.
April 15, 2024: The Richmond Times-Dispatch (Richmond, Va.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: The News & Advance (Lynchburg, Va.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: The Quad-City Times (Davenport, Iowa) ran TPA’s op-ed, “Don't trust agency with more power.”
April 15, 2024: Dan Savickas appeared on the Schilling Show (Charlottesville, Va.) to discuss Tax Day and Direct File.
April 15, 2024: Patrick Hedger appeared on Real America’s Voice to discuss Tax Day and Direct File.
April 16, 2024: Townhall.com ([link removed]) ran TPA’s op-ed, “Democrats Should Join the Call for FDA to Accelerate Approval of Smokefree Products.”
April 16, 2024: Real Clear Health ran TPA’s op-ed, “FDA Needs to Stop Saying 'Maybe' on mAbs.”
April 16, 2024: The Kearney Hub (Kearney, Neb.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Davis Enterprise (Davis, Calif.) ran TPA’s op-ed, “FDA finally realizes that yogurt is healthful.”
April 16, 2024: Tulsa World (Tulsa, Okla.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Martinsville Bulletin (Martinsville, Va.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Morning News (Johnsonville, S.C.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: The Press of Atlantic City (Atlantic City, N.J.) ran TPA’s op-ed, “Don't trust IRS too much.”
April 16, 2024: American Family News quoted TPA in their story, “Gov't giving green light to make problem worse.”
April 16, 2024: The Hickory Daily Record (Hickory, N.C.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Journal Times (Racine, Wise.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Grand Island Independent (Grand Island, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: The Kenosha News (Kenosha, Wisconsin.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 16, 2024: Inside EPA mentioned TPA in their story, “Host Of Industry Groups Press EPA To Reject California Locomotive Waiver.”
April 17, 2024: The York News-Times (York, Neb.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 17, 2024: The Herald & Review (Decatur, Il.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 17, 2024: The Pantagraph (Bloomington, Il.) ran TPA’s op-ed, “Don't trust agency with more power.”
April 18, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about polling about the Kirwan Commission.
April 18, 2024: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about tariffs and antitrust.
April 18, 2024: Real Clear Markets ran TPA’s op-ed, “The FTC's Unhealthy Obsession With Private Equity.”
Have a great weekend!
Best,
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 1120
Washington, D.C. xxxxxx
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