Regulatory Focus™ > News Articles > 2020 > 11 > HHS moves to end FDA’s unapproved drugs initiative

HHS moves to end FDA’s unapproved drugs initiative

Posted 24 November 2020 | By Michael Mezher 

HHS moves to end FDA’s unapproved drugs initiative

Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs.
FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs). In 2011, FDA issued an updated CPG and announced it would step up its enforcement of the program.
The aim of the program was to push drugmakers to bring products that have been on the market since before 1938 through its review program so they can be evaluated for safety, effectiveness and quality.
According to FDA, “Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.” FDA says it has removed hundreds of potentially unsafe unapproved drugs from the market since the program’s inception in 2006.
FDA also acknowledges that the program may have an impact on drug pricing. “When there is a sole source of an FDA-approved drug, market dynamics may enable the company that sought approval to set a higher price than when the drug faces competition,” FDA writes, noting that the tradeoff for patients is more certainty about the benefits and risks of their medication.
“We are committed to putting American patients first by ending government programs like the Unapproved Drugs Initiative that, while well-intentioned, have distorted markets and produced the unintended consequences of price spikes and drug shortages.” said HHS Chief of Staff Brian Harrison.
In a Federal Register notice, HHS explains that it is withdrawing both of FDA’s CPGs on marketed unapproved drugs and terminating the program and asserts that the period of “de facto market exclusivity” offered by FDA to incentivize companies to seek approval “allowed manufacturers an opportunity to raise prices in an environment largely insulated from market competition.”
During a press conference on Friday, Trump called the program “misguided” and said it has caused the prices of some old drugs to increase by 1,000-5,000%. However, in its documents, HHS calls the initiative “laudable” and notes that a 2017 Yale study found the average price increase across 26 drugs approved through the program was 37% (IQR 23-204%). The study also found the program led to some shortages and did little to generate new clinical evidence.
On Twitter, one of the authors of the Yale study, Joseph Ross, professor of medicine at the Yale School of Medicine, pointed to suggestions for mitigating the unintended consequences of the program discussed in the study and said the program “needs to be fixed, but by FDA, not HHS”.
Aaron Kesselheim, professor of medicine at Harvard Medical School, told Focus that it’s true that prices for a small number of drugs that went through the program went way up. “The program was generally a good idea – it is better to try to bring remaining drugs from before the 1938 [Federal Food, Drug, and Cosmetic Act] FDCA under the FDA’s umbrella than have them remain in regulatory limbo,” Kesselheim said, adding that the program may not have been implemented ideally in some cases.


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