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FDA Drug Review Deadline May Be Extended

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Christina Houghton6 years ago

U.S. regulators and the drug industry want to extend the deadline for the Food and Drug Administration to approve or reject new drugs by two months. The time extension is part of a new deal between the FDA and prescription drug companies. The FDA claims that it will need an extra 60-day “filing date” before their 10 month deadline to review new drugs, or six months for a priority review.

The new potential agreement, that was announced on the FDA’s website last week, will last five years, and comes as the FDA receives increased criticism from Congress and the industry for being too slow. Many say that approving new products too leisurely is slowing innovation and the creating of new jobs.

According to the FDA

Many people wonder what the FDA will use this extra time for in the already slow process. However, according to the FDA, it will use those two months to really prepare for the review. This also frustrates many because the Prescription Drug User Fee Act gives the FDA millions of dollars a year to review the U.S. market in exchange for a quicker turnover. Also, the PDUFA expires in September of 2012, and whether or not this new deal goes into effect, the FDA may have a difficult time reenacting it.

Ryan Hohman, the director for communications and policy at Friends of Cancer Research said, “If you look at the original PDUFA, all of that went directly to just review processes, but the FDA and industry stepped back and recognized that in the economic environment, they need to have the increase in science or else they wouldn’t be able to approve these drugs at a speedy time for patients.”

The fee system for the FDA is already highly controversial, about a third of the agency’s funding comes from makers of drugs and medical devices which could potentially influence the FDA’s decisions. That number could also continue to grow if the FDA’s new agreement with generic drug-makers goes through.

Although the FDA is receiving a lot of criticism for wanting more time to approve or reject new drugs, it may be a good thing for consumers. If the FDA has the time it needs to more thoroughly research new drugs, then this may lead to fewer recalls.

Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

Your choice does matter. If you or a loved one has suffered serious injuries because of any defective drugs and/or products, call Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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