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Bill tying FDA review timelines to EU approvals questioned

By Fiona Barry , 01-Jul-2014

Bill tying FDA review timelines to EU approvals questioned

A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.

US Congressman Steve Stivers (Republican, Ohio) said he introduced the Speeding Access to Already Approved Pharmaceuticals Act to fight “the United States FDA’s red tape” which he claimed “causes delays of up to several years in approval for life-saving and life-changing medical treatments.

But regulatory expert Matthew Weinberg told in-Pharmatechnologist.com the legislation is unlikely to have the impact intended. “It’s not an idea whose time has really come. There’s going to be a massive number of unintended consequences,” said the CEO of pharmaceutical drug regulatory consultancy The Weinberg Group.

Two problems

The FDA and the European Medicines Agency (EMA) have “different philosophical foundations,” he explained.

The FDA and the EU have different processes that they use to evaluate and determine the safety and efficacy of pharmaceutical products. They’re both very viable but they’re different and they reflect differences in the agencies. Simply because a product is approved in Europe, to say it should be approved in America – that doesn’t work. There are about 12 to 15 products that have been approved in one area but not another.”

Expediting drug reviews could force the FDA to reject submissions on safety grounds if it does not obtain all relevant data on time, he said. 

A possible unintended consequence is if you force FDA to do something, they’ll say they don’t have enough information to make a decision. They could reasonably say no because they don’t have enough data.

If FDA now has 90 days to evaluate it, the odds are the agency will be forced to say ‘we don’t know.’

It’s not their job to get new drugs on the market as fast as possible; it’s their job to protect American lives.

A second potential problem, said Weinberg is that pharmaceutical sponsors are likely to turn first to Europe for approval. “If I’m a pharma company and I apply for approval in Europe and do nothing in the US, the US has to review me in 90 days. That doesn’t even make sense. A 90-day review of a new drug is unheard of in this country for good reason.

Drug lag

Weinberg told us while the proposed legislation is not appropriate, there is no obvious alternative fix to delays in drug approvals.

The people who work for the FDA are very committed to doing a great job. But it might help if they had more resources; it’s a little bit bureaucratic at times. While it’s modernised and is better than it used to be, there are more and more drugs now entering into the market, and they’re more complicated medicines.

Weinberg also pointed out that the so-called drug lag “isn’t always and only about the US being behind Europe – there are many times when the FDA approves before the Europeans.

The bill, co-sponsored by Congressman Tim Ryan (Democrat, Ohio), is currently referred to the House Committee on Energy and Commerce. The FDA told this publication it was not able to comment on pending legislation.

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