Post Market & Phase IV Drug Studies


post market FDA phase IV

Phase IV Studies Under Increased Scrutiny

Phase IV drug research, post market studies, don’t have a good reputation. FDA regulations share some of the blame. One time when I was still an FDA field investigator I was assigned to look into a complaint about a clinical trial. However, it turned out that there wasn’t much I could do but listen to the complainant and write up a report. You see, the complaint was about a Phase IV study of a drug that was already approved. FDA clinical trial regulations only cover “New Drugs,” those still being tested to prove safety and effectiveness prior to receiving FDA approval for its indicated use. Hundreds of clinical trials are conducted every year that are not inspected by FDA. They are post-approval studies that FDA periodically requests as a condition of approval when FDA wants to review additional data about a drug’s safety. Also a drug company may conduct a Phase IV study just to help market their drug.

Reuters has just published “good news” that drug companies are finishing more of the post-marketing studies than originally believed. See the link on the Blogroll, “11: Reuters on post market studies.” A study conducted by the consulting firm Booz Allen Hamilton Inc., a favorite of FDA, found that 501 of 1531 post marketing studies requested by FDA have actually been completed. The others are reportedly in the process of completion although 15% have been “delayed.”. However, FDA has only reviewed 23% of the studies in the one year they are supposed to. Not a good track record. Two major industry organizations, BIO and PhRMA, have lauded the findings which are posted on FDA’s web page.

Critics have a different opinion. According to Reuters: Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said even if companies finish such studies, the results don’t necessarily provide useful information. She said patients are not necessarily tracked as well as in trials done before approval.

“I’ve repeatedly seen longitudinal studies where more than half the patients have dropped out and nobody knows if they are alive or dead, healthy or sick,” she said. “So, the studies might be completed, and might be on time, but might not provide useful information on safety or effectiveness — which is what post-market studies are supposed to do.”

There is another point to consider. FDA does not conduct any inspections to determine the quality of post marketing studies. As I found out seven years ago when I investigated an insider’s complaint, the regulations aren’t there and there just isn’t an inspection program. There are no requirements that the studies meet any quality standards. So critics just might have a point.

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