Federal Laws That Shield Big Pharma From Competition.

Brand-name manufacturers impede the entrance of generic products into the marketplace.

The FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests.

Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11

The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12

Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14

Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price.

For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own.

Abortion Pills

Abortion pills pose the single greatest threat to unborn children in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical.

The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days (10 weeks) into pregnancy and before Biden was subject to a heightened safety restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires an in-person visit with a physician who can check for dangerous contraindications such as ectopic pregnancies and can advise the mother seeking an abortion of the risks of chemical abortion, including hemorrhaging, and what to do in such cir- cumstances. Chemical abortion has been found to have a complication rate four times higher than that of surgical abortion.

Since its approval more than 20 years ago, mifepristone has been associated with 26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands more adverse events, but that number does not account for all complications. Of course, this does not count the hundreds of thousands to millions of babies whose lives have been unjustly taken through chemical abortion. FDA should therefore:

Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. It never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen. Furthermore, at no point in the past two decades has the FDA ever acknowledged or addressed federal laws that prohibit the distribution of abortion drugs by postal mail; to the contrary, the FDA has permitted and actively encouraged such activity.

Now that the Supreme Court has acknowledged that the Constitution contains no right to an abortion, the FDA is ethically and legally obliged to revisit and withdraw its initial approval, which was premised on pregnancy being an “illness” and abortion being “therapeutically” effective at treating this “illness.” The FDA is statutorily charged with guaranteeing the safety and efficacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children.

As an interim step, the FDA should immediately restore the REMS by removing the in-person dispensing requirement to eliminate dangerous tele-abortion and abortion-by-mail distribution.

Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion industry that allows it to expand far beyond brick-and-mortar clinics and into pro-life states that are trying to protect women, girls, and unborn children from abortion. The FDA should therefore:

Address weaknesses in the current FAERS (FDA Adverse Events Reporting System).

The Administration and policymakers should ensure that health care workers, particularly those in hospitals and emergency rooms, report abortion pill complications. Women who experience complications from abortion pills typically go to an emergency room, not to the abortion pill prescriber, so putting the onus of reporting on the prescriber who typically has no idea that a complication has occurred means that the FAERS is seriously undercounting adverse events. Submitting an adverse event to the database should be a quick and efficient process for busy health care practitioners. Currently, providers report that the process is difficult and convoluted. Implement a policy of transparency about inspections of the abortion pill’s sponsors, Danco and GenBioPro, as well as facilities that manufacture the pills. The FDA should respond to congressional requests and Freedom of Information Act (FOIA) requests about inspections, compliance, and post-marketing safety in a timely manner. Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.16

Vaccine Importation. Thousands of Americans of faith and conscience wish to receive various childhood vaccinations for themselves and their families but are not allowed to receive vaccines that are derived through or tested on aborted fetal cells. For example, the chickenpox, Hepatitis, and MMR vaccines in the U.S. are all linked to abortion in this way. There are ethically derived alternatives abroad that have been used safely there for decades, but the FDA makes it exceedingly difficult for Americans to import them.

In January 2021, the HHS Office for Civil Rights (OCR) and the FDA jointly announced that HHS was required by the Religious Freedom Restoration Act

Reinstate earlier safety protocols for Mifeprex that were mostly eliminated in 2016 and apply these protocols to any generic version of mifepristone. A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women’s health and safety.

(RFRA)17 to allow bulk importation by doctors of certain Japanese-made vaccines to accommodate religious needs of patients, but the Biden FDA unlawfully revoked this waiver. The FDA should restore the waiver to comply with RFRA and for the obvious public health benefits of increased childhood vaccination by families seek- ing ethically derived alternatives.

To avoid future moral coercion of the sort experienced with the COVID-19 vac- cines, the FDA and NIH should require the development of drugs and biologics that are free from moral taint and switch to cell lines that are not derived from aborted fetal cell lines or aborted baby body parts.

Conflicts of Interest. A 2018 report in Science found that more than two-thirds of FDA reviewers later ended up at the same companies whose products they had been reviewing while they were working for the government.18 This revolving door is one mechanism by which pharmaceutical companies capture the agencies that regulate them. The FDA should impose a lengthy cooling off period for reviewers, preventing them from working for companies they regulated.

In 1997, the FDA relaxed regulations to permit broadcast drug advertisements, after which Big Pharma began routine direct-to-consumer advertising, making the United States and New Zealand the only countries where such practices are legal. Following the 1997 changes, pharma became the largest advertiser for all major media organizations. This buys considerable influence in the newsroom—whether media companies acknowledge this or not—and distorts independent reporting on public health issues. The FDA or Congress should regulate where and how paid advertising is used by pharmaceutical companies more stringently, especially on media outlets.