Is the FDA Really That Slow at Approving Drugs?

Heart Failure Drug Rejected, Rejected Again, Then Approved, What’s Up?
Heart Failure Drug Rejected, Rejected Again, Then Approved, What’s Up?
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Criticism that the FDA doesn’t approve drugs fast enough ignores the fact that most drugs are approved in the US first and within regulatory timelines.

One of the most often heard complaints about the FDA is that it is too slow to approve drugs.

During his first address to Congress in February, President Trump said that the agency is saddled with a “slow and burdensome approval process” that is keeping many drugs from getting to patients. He has also called for slashing regulations at the FDA as one way to speed up the approval process.

Congress has also pushed for faster approval through the 21st Century Cures Act. One of its provisions would allow the FDA to accept less rigorous clinical trials conducted by drugmakers to demonstrate a new drug’s safety and efficacy. This means that trial durations would be shorter, and there would be fewer people enrolled in the trials. While this could potentially lead to more drugs coming to the market, they could carry more risks and be less effective due to lowered standards for approval.

With all these attempts to get drugs approved faster, I wondered whether the FDA really is slow in approving new drugs.

The answer is a resounding no.

A new drug is more likely to get approved in the US before it does in any other country.

The FDA is already, without a doubt, the best drug regulatory agency in the world when it comes to drug approvals. A new drug is more likely to get approved in the US before it does in any other country. Last year, of the 22 new drugs that were approved, 19 were approved in the US first. Eight of them were deemed “first-in-class” medications, meaning they are truly innovative and work differently than present therapies for a condition. Also, all but one of them came in the “first cycle” of review, meaning the FDA didn’t delay approval for additional information from a drugmaker.

The FDA Is Ahead of Europe’s EMA in Approvals

A couple of recent studies highlight that when it comes to approving drugs, the FDA is already doing an excellent job. Between 2011 and 2015, the FDA approved 170 new drugs compared to just 144 by the European Medicines Agency (EMA), according to an April report published in the New England Journal of Medicine. The median review time was 303 days at the FDA compared to 383 days at EMA. The review also showed that over the same time period, the FDA approved 43.5% of applications for drugs to treat orphan or rare diseases, compared to just 25% at EMA.

A June analysis in the BMJ looked at the time drugmakers took to submit an application for a new heart or kidney drug to the FDA, as well as the time the FDA took to evaluate it. The analysis was based on 15 heart and kidney drugs reviewed by the FDA between 2011 and 2015.

After completing clinical trials, a pharmaceutical company, on average, took 12 months to submit an application for the drug’s approval. The study’s authors say that this indicates that the flack FDA often receives about acting slowly may be misplaced. “This crude depiction ignores industry’s contribution to the clock after clinical trials are completed but before the FDA receives the formal application,” they wrote.

For its part, the FDA took an average of 7 months to finish its scientific review for the new drugs, plus an additional 3 months for top brass at the agency to decide whether or not to grant approval. Once the FDA accepts an application for review, regulations give the agency 10 months for a standard review. This means that the FDA mostly was on time with its reviews and decisions.

The authors also write there might be some ways to speed up drug approvals by changing some processes earlier in the drug development process. But they say that lowering standards to accelerate reviews -– as would happen under the 21st Century Cures Act -– would be a mistake and “may be costly for patients.”

I agree.

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