FDA’s Deadly Delay

Every year, 2 million Americans receive the dreadful news that they have cancer. Getting a handle on the devastating disease requires immediate and continuous treatment ranging from chemotherapy to surgical intervention. Unfortunately, recent medication shortages have made beating cancer far more difficult than it needs to be. According to a June survey by the National Comprehensive Cancer Network, more than 90 percent of cancer centers are facing shortages of carboplatin and cisplatin, which are platinum-based chemotherapies. The shortages were spurred by the Food and Drug Administration’s (FDA’s) temporary closure of an Indian drug manufacturing facility, and the agency has done little to offset the disruption. America’s drug regulator must act fast to get chemotherapies to patients who desperately need them.

The trouble began in December 2022 when the FDA wrapped up an inspection on India-based chemotherapy manufacturer Intas Pharmaceuticals and subsequently wrote a scathing 36-page report detailing the many problems at the plant. Test procedures and laboratory control mechanisms were “not being followed,” and critical documents related to “Good Manufacturing Practices” guidelines were nowhere to be found. Operations grinded to a halt, and the ripple effects were almost immediately felt in the U.S. Clinics have started switching patients to other platinum-based chemotherapy treatments less impacted by the Intas fiasco, but this has resulted in a “whack-a-mole” game of substandard substitutions and shortages. The FDA has since allowed Intas to partially resume production under strict supervision and permitted importation of unapproved, China-manufactured medications. But, the FDA’s decision to allow imports from foreign companies such as Qilu Pharmaceutical is likely a one-off, and unlikely to
lead to bolstered supply over the long-term. Indian and Chinese drug manufacturers often face difficulties recruiting a diverse population to conduct clinical trials, making it less likely that their products will garner FDA approval. In March 2022, the FDA issued a denial for a Chinese-produced drug called sintilimab for the treatment of nonsquamous non-small cell lung cancer. In briefing documents for the Oncologic Drugs Advisory Committee, agency regulators cautioned that, “[t]he current trend of marketing applications to the FDA, based on foreign data from single country trials, is a departure from decades of MRCTs [multiregional clinical trials] as the consistent approach to drug development.” While the FDA acknowledged that the drug has been studied using a randomized, double-blind trial design and the study (called “ORIENT-11”) met its primary endpoint (progression-free survival), the agency voiced skepticism about the results’ applicability to the U.S. population.

The FDA can alleviate shortages of these and all life-saving medications by relaxing its approval criteria and approving promising medications manufactured abroad. While these companies’ clinical trials are not as broad as the FDA would prefer, the agency shouldn’t let the perfect be the enemy of the good. Regulators could use post-approval monitoring to ensure that warnings on labels are up-to-date and reflect the experiences of different populations of users. Millions of lives depend on a flexible regulatory approach grounded in free trade and international cooperation.


Travesty in Traverse City

In the last couple of years, more than $42 billion in federal taxpayer money has been allocated for broadband. A large chunk of this money will go for government owned networks (GONs). TPA’s two reports, GON with the Wind: The Failed Promise of Government Owned Networks Across the Country ([link removed]) and “GON with the Wind II: Frankly, Taxpayers Do Care,” ([link removed]) detail the billions of taxpayer dollars wasted on failed broadband projects. Now, despite the financial struggles of the government-owned broadband network in Traverse City, Michigan, city leaders there intend to borrow more money to expand the fiber infrastructure. Traverse City commissioners voted in April to provide a public notice (as required by state law) that the city intends to borrow another $10 million for the broadband project, according to The Ticker. A feasibility report used by Traverse City Light &
Power (TCLP) to guide its plan estimated a take rate of 40 percent would be needed to make the project financially viable, projecting a take rate of 50 percent by the second year. So far, two years into the project, only about 25 percent of local residents and businesses have signed up for the service, Michigan Capital Confidential (CapCon) reported. Traverse City resident Gerald DeGrazia, a retired telecommunications executive, told CapCon that the original business plan was “flawed with overly optimistic customer assumptions and lower than required capital outlay assumptions.” In 2019, the estimated project cost was $16.3 million. That has now ballooned to $28.2 million. From delays in the U.S. Department of Agriculture (USDA) in releasing funds from a $14.7 million loan to inflation and rising interest rates, commissioners blamed a number of factors for the need to borrow more money during an April meeting.

When the city was still considering the project in 2019, the Taxpayers Protection Alliance (TPA) called it a “foolish plan” because the concept had plenty of factors going against it. This included nearly every resident of the 15,000-population city already receiving terrestrial broadband service through Spectrum and plans to build infrastructure to support 10 gigabit internet when 1 gigabit more than satisfies the needs of almost every user. In addition, Traverse City received the USDA loan intended for underserved areas when there were undoubtedly more needy areas in Michigan.

The Traverse City charter requires the debt to be backed by the city’s credit, but TCLP is responsible for paying it off. TCLP Chief Financial Officer Karla Myers-Beman said the additional $10 million includes $4.3 million in contingency costs, providing the utility flexibility to cover additional costs without having to make another funding request. TCLP did receive some pushback at the meeting. Former city treasurer Bill Twietmeyer pointed to the low take rates and asked what would happen if the project proves to be a “financial failure.” Myers-Beman said in the worst-case scenario electric customers would see a 4.5-percent rate increase to cover the debt payments. Traverse City leaders say they have wait lists of people in still unreached residential areas wanting to subscribe to the city’s internet service. Hopefully, take rates will increase so that power customers aren’t subsidizing a service hardly anyone in the city wanted or needed.

BLOGS:


** Wednesday: DeSantis is wrong about tariffs and industrial policy ([link removed])
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** Thursday: State Bill of the Month: Act providing for Property Tax Relief for Small Business Owners ([link removed])
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** Friday: 5G Booms In China, As Congress Charts A Future For FCC Spectrum Authority ([link removed])
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Media:

June 30, 2023: TPA was quoted in an article in The American Spectator titled “Anti-Business Activism Behind the FTC’s Lawsuit Against Amazon.”

July 2, 2023: The Washington Examiner (Washington, DC) ran TPA’s op-ed, “DeSantis is wrong about tariffs and industrial policy.”

July 2, 2023: The Traverse City Record Eagle (Traverse City, Michigan) ran TPA’s op-ed, “City broadband system looks to be latest taxpayer boondoggle.”

July 4, 2023: WBFF Fox45 (Baltimore, Md.) interviewed me about student loan debt and the Supreme Court.

July 5, 2023: WBFF Fox45 (Baltimore, Md.) quoted TPA in their story, “Timeline for Brooklyn mass shooting raises questions for BPD, Safe Streets.”

July 6, 2023: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about gas prices and White House coordination with social media..

July 6, 2023: WBFF Fox45 (Baltimore, Md.) interviewed me about accountability issues after the mass shooting in Baltimore.

July 6, 2023: Issues & Insights ran TPA’s op-ed, “5G Booms In China, As Congress Charts A Future For FCC Spectrum Authority.”

Have a great weekend!

Best,
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 1120
Washington, D.C. xxxxxx
www.protectingtaxpayers.org ([link removed])

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