Yesterday was Groundhog Day and of course many people joked about Punxsutawney Phil seeing his shadow meaning there’s 6 more weeks of winter. That’s not what I was thinking. I was reminded of the movie Groundhog Day starring Bill Murray. Murray’s character keeps on repeating Groundhog Day over and over again.  Kind of like Congress repeating each day by spending more and not cutting spending.  Well, the debt ceiling has been reached, so now is the perfect opportunity to insist on spending cuts before any deal is reached. And, just in case they don’t know where to cut spending, Sen. Rand Paul (R-Ky.) put out his annual Festivus release highlighting $500 billion in wasteful spending. Time to get out of this time loop and pass spending cuts.
 
Profile in Courage – Rep. Patrick McHenry
 
Most of the time, it is all too easy to guess a lawmaker’s stance on any given issue by looking at the letter next to their name. Rep. Patrick McHenry (R-N.C.) defies conventional partisan politics, choosing instead to tackle the big issues of the day his way. He worked across the aisle to ensure that more entrepreneurs had access to the capital needed to deliver on the next big idea through reforms to the crowdfunding regulatory process. Now, he’s facing one of the biggest policy battles of his career. The lawmaker has rightly been critical of attempts by the Biden administration to mandate that companies disclose their environmental, social, and governance (ESG) investment strategies, and has assailed bureaucrats for overstepping their bounds. Rep. McHenry has also pushed back against his Republican colleagues attempts to penalize businesses simply for making environmentally conscious investments. And, for having the courage and bravery to stake a rare, reasonable position on this pressing policy issue, Rep. McHenry is a Profile in Courage.
 
Rep. McHenry has served through his fair share of presidential administrations and Congresses. Even before coming to Congress, he served as a special assistant to the U.S. Secretary of Labor in the Bush administration. By working on early efforts by the Bush administration to streamline and clarify overtime rules and strengthen whistleblower protections, Rep. McHenry learned the value of an efficient, responsive federal government. The lawmaker was first elected in 2004 at age 29 and has since been re-elected an astounding nine times. Rep. McHenry earned the trust of his constituents by striving to stay above the partisan fray and work on real solutions that would benefit the households and businesses of his district. In 2011, he introduced the Entrepreneur Access to Capital Act, which proposed allowing people to invest equity in start-ups through crowdfunding without having to deal with onerous Securities and Exchange Commission (SEC) rules. Rep. McHenry’s sensible reform was ultimately rolled into the Jumpstart Our Business Startups (JOBS) Act and signed into law by former President Obama in 2012. While the reforms were undermined by the Washington legislative process, the new status-quo is surely an improvement for millions of investors and entrepreneurs. But, federal agencies such as the SEC can only be held in check for so long. In 2022, the SEC proposed new rules that would require public companies to disclose a wealth of data related to climate risks and investments. The Taxpayers Protection Alliance, and 16 other watchdog groups, criticized the proposal in a letter to the SEC, pointing out that the “reform” exceeded the scope of the Commission’s authority and would cost businesses up to $640,000. Rep. McHenry also weighed in, slamming the Biden administration for, “pushing its climate agenda through financial regulators because they don’t have the votes to pass it in Congress.”
 
As chairman of the House Financial Services Committee, the lawmaker has signaled that he’ll apply close oversight to the SEC rulemaking process. Unlike some of his colleagues, Rep. McHenry is not interested in punishing companies for their ESG-related investments. His role is keeping bureaucracy and red tape under control, not bossing around or boycotting companies based on whether they’ve made the “right” investment choices. This perspective is a valuable one, as lawmakers from both sides of the aisle increasingly attempt to harass companies they don’t like. Whether Rep. McHenry’s efforts to walk a fine line will make him a pariah among Republicans remains to be seen. But, no matter the outcome, Rep. McHenry is courageous for sticking to his beliefs and holding agencies such as the SEC accountable. For being a rare voice of reason in an overcharged, hyper-partisan environment, Rep. Patrick McHenry is certainly a Profile in Courage.
 
FDA Waist Watch
 
America has a love-hate relationship with weight-loss drugs. A silver bullet to ward off obesity always seems to be around the corner, but there’s always the risk of a “miracle drug” turning into the next Fen-Phen and causing life-threatening injuries. A new crop of weight-loss medications is coming on the market that can seemingly burn fat without the infamous side effects of yesteryear. These therapies can save millions of lives but only if the Food and Drug Administration (FDA) green-lights patient access. It’s time for America’s drug regulator to trim the regulatory fat, turbocharge innovation and transform healthcare. For the 50 percent of American adults actively trying to lose weight, a class of diabetes medications offers some much-needed hope. These glucagon-like peptide 1 (GLP-1) agonists are designed to help regulate blood sugar levels, but the medications also appear to curb appetite. Studies indicate that medications such as semaglutide (approved by the FDA for diabetes control in 2017 and weight loss in 2021) can help patients lose 10 percent to 15 percent of their starting weight with minimal side effects.  Through-the-roof demand for Wegovy, the version of semaglutide for weight loss, has led to supply shortages. Patients have responded by getting their doctors to prescribe Ozempic, the version approved for diabetes. As a result, diabetes patients have had difficulty getting access to the medications they need to control their disease. Spikes in patients’ blood sugar levels spurred by supply snafus can lead to long-term health complications, including heart and kidney disease.
 
The FDA could help by approving new, similar drugs and green-lighting weight loss indications for medications currently approved only to fight diabetes. The agency is considering approval of the anti-diabetes drug tirzepatide for weight loss and is expected to make a decision in 2023. Expanded indications would go a long way in giving manufacturers the certainty they need to bolster production instead of guessing how often patients will request diabetes drugs off-label.  But, the FDA’s turtle-speed approach may hamper access. The agency approved fewer new drugs in 2022 than at any point since 2016, and there’s little indication the FDA is willing to let up its scrutiny. Last year, the agency rejected hepatitis medication bulevirtide even though the drug had already been approved by the European Medicines Agency without incident. The FDA cited concerns regarding the manufacture and delivery of bulevirtide, even though these (unspecified) problems have proven non-issues on the other side of the Atlantic. Additionally, drug manufacturer Gilead received a rejection for the HIV drug lenacapavir for “Chemistry Manufacturing and Controls issues relating to the compatibility of lenacapavir with the proposed container vial.” The agency was concerned that vials made of borosilicate glass could produce sub-visible glass particles in the lenacapavir solution, potentially endangering patients. Gilead resubmitted its application in June, proposing an alternative, safer vial made of aluminosilicate glass. Despite this workaround and ample evidence of the drug’s safety and efficacy via the Phase 2/3 CAPELLA trial, the FDA waited an additional 6 months before finally approving the medication in December. The European Medicines Agency approved the product in August, allowing Europeans with multidrug-resistant HIV to construct an effective regimen for their illness.
 
The FDA’s reluctance to green-light drugs for easily resolvable issues doesn’t bode well for future GLP-1-related approvals. While manufacturing issues should not be ignored, they must be weighed against dire public health issues such as obesity. It is time for the FDA to embrace innovation and expand options for millions of patients. The right regimen of weight-loss drugs can save millions of lives, bureaucracy permitting.

BLOGS:

Monday: Taxpayers Protection Alliance Encourages House to Support COVID-19 Rollbacks 

Tuesday: Report Shows Software Contracts Cost Taxpayers Millions   

Wednesday: Government Watchdog Responds to Meta’s Approval to Acquire Within Unlimited

Thursday: Op-Ed: FDA Regs Are Bad for the Waistline

Friday: Op-Ed: The US Postal Service’s (Entirely Avoidable) Religious Liberty Fiasco

 
MEDIA:
 
January 30, 2023:  WBFF Fox45 (Baltimore, Md.) interviewed me about Maryland’s digital service tax.
 
January 30, 2023:  Inside Sources ran TPA’s op-ed, “FDA Regs Are Bad for the Waistline.”
 
January 30, 2023: Prescott E-News ran TPA’s op-ed “FDA Regs Are Bad for the Waistline.”
 
January 30, 2023: Dan Savickas joined ‘The Rod Arquette Show’ on Talk Radio 105.9 (Salt Lake City, Ut.) to discuss entitlement programs.
 
January 30, 2022: Dan Savickas joined ‘The Lars Larson Show’ (Nationally Syndicated) to discuss the recent stamp price hike.
 
January 31, 2023:  The Livingston Parish News (Denham Springs, La.) ran TPA’s op-ed, “Taxpayers and consumers cannot afford another stamp price hike.”
 
January 31, 2023: The Boston Herald (Boston, Mass.) ran TPA’s op-ed, “FDA regs are bad for the waistline.”
 
February 1, 2023: Talking Retail ran TPA’s op-ed, “Counterfeit vapes are undermining efforts to reduce smoking.”
 
February 1, 2023:  The American Spectator ran TPA’s op-ed, “The US Postal Service’s (Entirely Avoidable) Religious Liberty Fiasco.”
 
February 2, 2023:  WBFF Fox45 (Baltimore, Md.) interviewed me about overtime abuses at Baltimore Police Department. 
 
February 2, 2023:   I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about the debt ceiling and the new jobs numbers.
 
February 2, 2023: The National Desk interviewed me and quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: WKRC-TV Local 12 (Cincinnati, Oh.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: NBC24 WNWO (Toledo, Oh.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KRCR ABC 7 (Redding, Calif.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: CBS4 Local (El Paso, Tx.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: ABC News 4 (Mount Pleasant, S.C) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: ABC 8 KTUL (Tulsa, Okla.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KSNV News 3 (Las Vegas, Nev.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: News4SA (San Antonio, Tx.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KHQA (Quincy, Il.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: CBS2 Iowa News Now (Cedar Rapids, Ia.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: WTGS Fox 28 (Savannah, Ga.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: WZTV Fox17 (Nashville, Tn.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KFOX14 (El Paso, Tx.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: FOX 58 Bakersfield Now (Bakersfield, Calif.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: NBC Montana (Missoula, Mont.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: CBS2 Idaho News (Boise, Id.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KTVO (Kirksville, Mo.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.
 
February 2, 2023: ABC 33/40 (Birmingham, Al.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KOMO News (Seattle, Wash.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KCBY (North Bend, Ore.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: CBS 2 KUTV (Salt Lake City, Ut.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: Dayton 247 NOW (Dayton, Oh.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: WRGB CBS6 (Albany, N.Y.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KOKH FOX 25 (Oklahoma City, Okla.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: KTXS ABC12 (Abilene, Tx.) quoted me in their story, “GOP lawmakers call pandemic fraud 'greatest theft of taxpayer dollars in history'.”
 
February 2, 2023: Patrick Hedger joined ‘The David Webb Show’ (Nationally Syndicated) to discuss the stamp price hike, COVID-19 rollbacks, and the debt ceiling.
 
February 2, 2023: The Buffalo News (Buffalo, Ny.) ran TPA’s op-ed, “Gov. Hochul should stop gouging poor adults who smoke.”
 


Have a great weekend!