New Study Casts Doubt on FDA Shorter Drug Approval Timeframe

New Study Casts Doubt on FDA Shorter Drug Approval Timeframe

October 30th, 2013 // 6:28 pm @

Newer drug treatments that receive an expedited review by FDA are now being tested on fewer numbers of people. This can leave many safety issues open even after FDA approval. According to a study that was released by the Journal of the American Medical Assn., development timeframes, clinical tests and risks associated with twenty drugs were looked at. Eight of them had expedited review, and 12 of them had a standard FDA review.

It was determined that the expedited drugs had a median time of 5.1 testing years before they were FDA approved. This was compared to 7.5 years for drugs that had a standard review. But in a high number of cases, safety monitoring trials were not done or were not turned into the agency.

According to the study authors, new drug testing has gone away from where most of the testing was done, prior to approval, to a way that many of the more innovative drugs get approved after a small clinical trial in a very narrow population of patients.

Congress, pharma and FDA has in the last 10 years introduced several means to increase speed of drugs to market. This can help to get needed drugs to patients, but it also can lead to drugs getting the ok without full testing.

Of all of the drugs studied in this study, FDA had to do 85 follow up clinical trials to check for safety. As of this year, only 41% of the studies were finished.

Usually, FDA mandates that there are two controlled clinical studies done to prove that a new drug is effective and safe. Sometimes, the agency relaxes evidence requirements that it will accept for some products.

In those cases, FDA will then accept data from one trial and the success may be judged by surrogate measures, such as the shrinkage of a tumor, that may not always translate into a definitive measure, such as a higher survival rate.

FDAA is still talking about more measures that are needed to increase the speed of drug development, such as using enriched trials that would choose patients that are based on certain genetic or demographic themes, to boost the chances of the success of the trial.


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