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The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “laboratory-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.”

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 Laboratory Improvement Amendments (CLIA)," 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."

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 inspections 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.” Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH funding 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 US. are chemical rather than surgical.

The abortion pill regimen is typically a two-part process. The first pill, mifepristone, 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 contractions 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