Vaccines Are Safe. A Worrisome Portion Of Our Generic Drugs Are Not

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.

A Worrisome Share Of FDA-Approved Generic Drugs Are Unsafe

For at least 17 years, the U.S. Food and Drug Administration has consistently asserted that all FDA-approved generic drugs “have the same high quality, strength, purity, and stability as brand-name drugs.” Based on this assurance, drug wholesalers scour the globe to find companies offering the lowest price. U.S. pharmacies and health systems dispense whatever their wholesalers ship, and patients don’t worry about who manufactured their medication.

Unfortunately, they should. In a New England Journal perspective published in March, Stanford Professor Kevin Schulman and I challenged the FDA’s assertion that all is well. We noted that when price competition shifted most generic drug production offshore to countries with low labor costs and lax regulatory controls, it outstripped the FDA’s capacity to regularly inspect overseas manufacturers. It was only a matter of time before some companies cut corners on quality and safety.

To support our concerns, we cited FDA plant inspections that revealed glaring problems, agency decisions that prioritized minimizing drug shortages over product safety and documented instances of patient harm. We also shared data from an ongoing Department of Defense study of generic drug quality that determined that about 15% of FDA-approved manufacturers of 13 generic drugs produced medicine contaminated with heavy metals such as lead, thallium, or arsenic; dimethylformamide (a carcinogen) or dissolved too quickly or too slowly to be safe. An additional 12% of FDA-approved manufacturers made products of borderline quality. Only 73% were scored as good quality.

Since our paper was published, the analytical lab supporting the DoD study has tested multiple versions of 12 additional drugs with similar findings.

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.