Secretary Kennedy has basically accused much of the FDA and other parts of the HHS organization of being corrupt. One of his stated goals was to root out corruption. However, he never explicitly defined what the corruption was or identified any individual accused of it. Instead, he spoke of the revolving door where FDA employees with experience left the FDA to take high-paying industry jobs. He also spoke of his dislike for user fees, which he felt made the FDA “too cozy” with industry. He fired top FDA scientists and forced others out for not accepting his “brand” of science.
This morning, I read an article authored by Sarah Karlin-Smith of the Pink Sheet titled “US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions” (here, subscription required) that, as a former senior FDA official, made my hair stand on end. She wrote about the current politicalization of the FDA with its latest iteration being directly involved in price negotiations with the pharmaceutical industry. It is not a secret that the pharmaceutical industry is being pressured by the administration to lower drug prices. While that may be a good thing for the American public, placing the Agency that is responsible for drug-approval decisions in the crosshairs of pricing determinations might be a somewhat dangerous path to tread down.
For the most part historically when it comes to drug-approval decisions, the FDA has shied away from drug-prices issues. It has, in the past, taken steps to ensure access to a previously unapproved “grandfather”-type drug once a product received its first FDA approval by delaying enforcement action on the still unapproved versions until the new sponsor of the first FDA-approved product could ensure that they could meet market demand. The FDA has even had a hand in convincing firms that were charging significantly higher prices for newly approved versions of products than previously marketed unapproved versions to establish some form of assistance program to ensure that patients would retain access to the drugs. However, drug product approval decisions have never been based on the prices that sponsors chose to charge for their drug products. Using price as a lever to make approval decisions for drugs that the FDA has found safe and effective is not in any FDA statute or regulation and, certainly, in my opinion, not a function that should be involved in making scientific approval decisions.
Having what is supposed to be an apolitical agency, like the FDA, make drug prices part of approval decisions would certainly be a bad ethical look for the Agency. Can you imagine if the FDA’s findings of safety and efficacy were placed on hold until the FDA coerced firms into accepting price points that FDA felt were acceptable? Talk about the potential for introducing corruption into the drug review and approval process! It certainly could open the door to strongarming tactics. “Not going to play ball with the FDA? Then we’re going to either not approve your product or yank your approved product from the market because we think you’re charging too much.” I would certainly not want to roll the dice on that one!
