HHS Secretary Robert F. Kennedy Jr. has been quiet about vaccines in recent months, but behind the scenes, he is relentlessly pushing NIH scientists and federal contractors to prove that vaccines are unsafe. The effort appears aimed at validating several of his long-held beliefs, including his contention that vaccines are linked to autism, that thimerosal (a mercury-containing compound that prevents growth of harmful bacteria and fungi in multidose vials of flu vaccine) is dangerous, and that the minuscule amounts of aluminum salts added to several vaccines to boost immune response are “extremely neurotoxic.” The fact that decades of research have confirmed the safety of vaccines is irrelevant to Kennedy and his inner circle. If they are serious about finding and removing toxins that threaten patients’ health, they should look at our nation’s generic drug supply, most of which is imported from overseas.
Generic Drugs Play A Vital Role in American Healthcare
Because generic drugs are much less expensive than brand-name drugs, they account for only 20% of annual U.S. spending on medication. Nevertheless, they are hugely important to Americans’ health. They include life-saving medications used each day in hospital ICUs, ERs, transplant units, and cancer centers, and more than 9o% of outpatient prescriptions. Roughly 75% to 90% of older adults take one or more prescription drugs. For all these reasons, the quality, safety and security of our nation’s generic drug supply is of paramount importance.
The FDA Denies That There’s A Problem
Three months after our article was published, the FDA doubled down with a defensive commentary on its website. The authors, Dr. Ilan Murphy, Director of FDA’s Office of Generic Drugs, and Dr. Mike Kopcha, Director of its Office of Pharmaceutical Quality, dismissed past FDA, GAO and investigative reports, Congressional testimony by previous FDA administrators and scientists, peer-reviewed medical studies, analytical test results and documented cases of patient harm as “anecdotes and public concerns” that “may undermine confidence in generic drugs.” Near the end of their comments, they declared, “The agency remains committed to ensuring all drugs marketed in the United States, whether brand or generic, domestically manufactured or imported, meet rigorous quality standards.”
We Can Improve Drug Safety
If the FDA won’t tackle this challenge, HHS Secretary Kennedy should, because ensuring a reliable supply of safe, effective and affordable medicine is in everyone’s interest. If he won’t, Congress must.
Five actions could do wonders:
1) The FDA should stop asserting that all manufacturers of generic drugs sold in the United States make products that are equally safe and effective. 72% of manufacturers is not “all.”
2) To boost accountability, the FDA should encourage independent quality testing by accredited laboratories. If worrisome results are verified, the FDA should be immediately alerted. A similar approach in the European Union works well.
3) Quality scores should be shared with the public. A simple “red, yellow, green” rating scale could work well. This would create a powerful market signal to encourage high-quality manufacturing.
4) Congress could level the playing field for conscientious U.S. and overseas manufacturers by directing federal purchasers (including the DoD, the VA and CMS) to select generic drugs based on those that provide the “best value” rather than “lowest cost.” In many instances, high quality drugs cost little more.
5) To rebuild America’s capacity to make generic drugs, the federal government should incentivize construction of modern, highly-efficient manufacturing plants. U.S. public and private healthcare systems can help by signing long-term contracts with reliable domestic manufacturers.
The Bottom Line
A worrisome minority of FDA-approved manufacturers are shipping substandard or unsafe products to the U.S. Independent testing of finished drugs, sharing quality scores with the public and signing “green” manufacturers to long-term contracts would swiftly realign market forces to improve patient safety and produce better outcomes. It’s time to act.
