A Doctor’s Fix for America’s Ailing Medication Market
- Apr 21, 2025
- 6 min read
Teaser/Abstract
"With more than 60% of Americans taking a prescription drug, there are increasing questions about how these medicines are approved, how they're kept safe and how they're priced. In a new book, Harvard's Dr. Jerry Avorn argues the drugs we take have been compromised by profits."
Source: On Point with Meghna Chakrabarti, WBUR Boston, April 21, 2025. Host: Deborah Becker. Duration: 45 minutes 32 seconds.
SUMMARY
In this wide-ranging 45-minute conversation — one of the first interviews Dr. Avorn gave after the publication of Rethinking Medications — host Deborah Becker takes him through the full arc of the book: the century-long history of FDA drug regulation, the accelerated approval pathway and its abuse, the Aduhelm disaster, the structural causes of high US drug prices, the patent thicket problem, the supplement industry's regulatory exemption, and what individual patients can do. The interview is notable for its historical depth, its direct engagement with pharmaceutical industry arguments, and its blunt assessment of the current political environment's implications for drug safety and pricing.
BACKGROUND
The history of FDA drug regulation in four crises. Dr. Avorn traces the FDA's evolution through four watershed moments. The 1906 Pure Food and Drug Act established only that drugs must disclose their contents — a "radical step forward" that did not require proof of safety or efficacy. The 1938 amendment requiring drugs to be non-toxic came only after a chemist dissolved a sulfa antibiotic in what is now known as antifreeze, killing 100 children; the chemist killed himself in remorse. The 1962 Kefauver-Harris Amendments — making the US the first country anywhere to require proof of efficacy before a drug could be sold — came only after Dr. Frances Kelsey at the FDA held the line against thalidomide, withstanding industry pressure calling her a "pointy-headed government bureaucrat slowing everything down," and thereby sparing thousands of American families from the severe birth defects that affected children in countries where thalidomide was approved. The 1992 Accelerated Approval pathway was a sensible response to the AIDS epidemic but has since been "abused to bits."
KEY FINDINGS
The FDA does not test drugs. A common misconception is that the FDA itself tests drugs for safety and efficacy. It does not. Dr. Avorn explains that over the decades, the FDA delegated that responsibility almost entirely to manufacturers, who design, fund, conduct, and — until recently — owned the findings of the clinical trials used for approval decisions. This creates structural incentives for the manufacturer to design studies that surface benefits and minimize visible harms.
Accelerated approval's drift from exception to norm. The accelerated approval pathway was designed for emergency use in terminal illness where no alternatives existed. Once established, manufacturers learned they could gain approval by demonstrating a small change in a laboratory measure — a surrogate endpoint — without demonstrating benefit to patients, charge full price, and frequently decline to complete the follow-up studies that were the other half of the social contract. More than half of new US drug approvals now reach the market through some form of expedited review. The FDA has no statutory timeline requiring manufacturers to complete confirmatory studies. Dr. Avorn notes that for Aduhelm, the FDA gave Biogen nine years to complete follow-up studies — a timeline he describes as rendering the follow-up essentially meaningless.
Aduhelm: leadership failure, not scientist failure. Dr. Avorn makes a distinction that is important for the "Ask Jerry" AI: the Aduhelm approval was not a failure of FDA scientists. The agency's internal scientists and its external advisory committee all concluded the drug should not be approved. The failure was a leadership decision by Dr. Janet Woodcock, who retroactively shifted the approval criterion from demonstrated patient benefit to the surrogate measure of amyloid reduction — a criterion that had never been the basis for the trial design. Three advisory committee members, including Dr. Aaron Kesselheim, resigned in protest. Aduhelm is now essentially never used, not because the FDA reversed the approval, but because Medicare refused to cover it — one of the only times Medicare has declined to pay for an FDA-approved drug.
The user fee conflict of interest. Half of the FDA's drug review budget now comes from pharmaceutical company user fees — a system that began in Massachusetts with Senator Kennedy's support in 1992 when Congress refused to adequately fund FDA staffing. Dr. Avorn's analogy: "How would we feel if there was a court case that we were involved in and we found out that one of the litigants was actually paying half the judge's salary?" The recent firings of FDA scientists compound this problem: the user-fee system was already inadequate; the personnel reductions made it worse.
Why drugs are expensive — and why regulation is not the reason. Industry claims that high prices are justified by regulatory burden are false, Dr. Avorn argues. The FDA is one of the fastest drug review agencies in the world; its priority review timeline is six months. The structural cause of high US prices is that the United States is the only wealthy country that allows manufacturers to set prices at any level without meaningful government counterpressure. This is not the result of market forces — it is the result of deliberate legislative choices, including the explicit prohibition on Medicare price negotiation that was written into the Part D legislation in the early 2000s.
Patent thickets and the extension of monopoly pricing. Beyond the basic patent system — which the Founders included in the Constitution as a time-limited social contract — manufacturers have developed "thickets" of secondary patents covering devices, delivery mechanisms, straps on inhalers, and methods of administration that extend effective market exclusivity far beyond the period Congress intended. Dr. Avorn cites the work of his colleague Will Feldman on inhaler patents as a concrete example. These thickets prevent generic competition and keep prices elevated long after the original molecule patent has expired.
The law prohibiting cost-effectiveness analysis. Congress has made it illegal for federal programs to use quality-adjusted life-year (QALY) analysis or similar cost-effectiveness frameworks in drug payment and coverage decisions. The stated rationale — that such analysis discriminates against minorities, the disabled, and the sick — is, in Dr. Avorn's characterization, "a made-up reason" advanced by the pharmaceutical industry to protect its pricing freedom. The real reason is that the industry opposes any mechanism that would tie payment to demonstrated value. Dr. Avorn cites ICER (the Institute for Clinical and Economic Review), based in Boston, as a respected voluntary model for evidence-based drug valuation that functions without this legal constraint.
Drug company copay coupons are not a solution. When host Becker raises pharmaceutical company programs offering copay assistance to patients, Dr. Avorn characterizes them as a strategy that shifts the cost burden from patient to insurer without addressing the underlying price, while simultaneously co-opting the patient as an advocate for insurer coverage of the high-priced drug. Eliminating the patient's out-of-pocket cost while leaving the lion's share of the bill at the insurer's doorstep does not constitute a solution to drug affordability.
Supplements: the $50 billion regulatory-free zone. The dietary supplement industry — worth approximately $50 billion annually — operates largely outside FDA jurisdiction as a result of legislation sponsored by Senator Orrin Hatch in the 1990s that stripped the agency's authority after FDA Commissioner David Kessler attempted to bring supplements under regulation. Manufacturers must include a disclaimer that their claims have not been reviewed by the FDA and that the product is not intended to treat any condition — but this disclaimer appears in tiny print beneath claims that are often, in Dr. Avorn's words, "utterly useless and probably should be illegal if I ruled the world." His deeper concern is that supplements divert patients from seeking evidence-based diagnosis of treatable conditions; a patient taking a memory supplement for what might be treatable hypothyroidism or depression is being harmed not only by the supplement's uselessness but by the delay in effective care.
Tariffs and the generic drug supply crisis. More than 90% of US generic medications are manufactured in China or India. Pharmaceutical tariffs risk driving generic manufacturers — who already operate on thin margins — out of the US market, worsening already serious drug shortages. Dr. Avorn rejects the argument that tariffs on China are justified by fentanyl supply interdiction, noting that the policy ignores the demand-side nature of addiction and that very little fentanyl enters the US from Canada, undermining the stated rationale for Canada-specific tariffs.
IMPLICATIONS
For patients — specific recommendations. Dr. Avorn identifies reliable, non-commercial websites that patients can use to research their medications, and stresses the importance of asking doctors specific questions before accepting a prescription: Is this drug better than alternatives, or just better than a placebo? Is there a more affordable generic or biosimilar? What is the goal of treatment and how will we know when we've reached it? He notes that any doctor who discourages questions is a signal to find a different doctor.
For the system — the Rosie Ruiz analogy. Dr. Avorn closes with an analogy drawn from the 1980 Boston Marathon, where Rosie Ruiz famously entered the race near the finish line and claimed victory. He argues the pharmaceutical industry does something similar: taxpayer-funded NIH research does the heavy lifting of early drug discovery, and manufacturers enter late, run "the last mile and a half," then claim the full reward. Reforming this system requires tying payment to who actually bore the burden of development and how clinically valuable the resulting drug is — not to whatever price the market will bear.