The FDA might speed up the review process for drugs that have already received marketing approval in Europe, if a new bill introduced in the House of Representatives goes through.
Called the “Speeding Access to Already Approved Pharmaceuticals Act,” the bipartisan bill was actually first introduced last June. The bill addresses the issue of “drug lag” – the often long span of time between drug approval in one country compared to another. It has been sponsored, in both cases, by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH).
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“Unfortunately, the United States FDA’s red tape causes delays of up to several years in approval for life-saving and life-changing medical treatments,” Stivers said last year.
“There are too many examples around the country of illness outbreaks that can be successfully treated with medications that have been approved by the EU and are delayed in the FDA approval process,” Ryan added.
That said, the FDA is actually known for its speedy approval process for new therapies. As RAPS.org points out, a recent study from the Centre for Innovation in Regulatory Science finds the FDA approves new pharmaceuticals more quickly than regulators in other countries – and has done so for the past decade. However, according to RAPS:
But while FDA approves between 66% and 74% of drugs before anywhere else in the world, a handful of drugs are approved elsewhere—including Europe—first.
That discrepancy has drawn the attention of the US’ former top medical researcher, Elias Zerhouni, the former head of the National Institutes of Health (NIH) and now the head of research and development at the biopharmaceutical giant Sanofi.
In remarks made at the European Medicines Agency (EMA) on 18 March 2015, Zerhouni said a lack of regulatory consistency between regulatory bodies, including FDA and EMA, was baffling. “In my short experience of five years, I have not seen a single regulatory decision that was fully consistent across regulatory agencies,” he said, according to Reuters.
The gap is all the more perplexing due to a convergence of regulatory standards between bodies like FDA and EMA, which have harmonized pharmaceutical regulatory standards through international groups like the International Conference on Harmonisation (ICH).
What hasn’t been harmonized, Zerhouni noted, is standards of risk and benefit—the ultimate arbiter of whether a drug can and should be approved by a regulatory body.
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There are, however, some grey areas in the bill, RAPS notes – such as ambiguous language around which Europe-approved drugs will actually receive expedited review in the U.S. It’s also unclear how the regulatory processes would actually work if the bill were enacted – sometimes, for instance, drug lag is pretty negligible when drugs are approved in the EU and US within a small window of time. Further, European regulators require different research and clinical trial data than the FDA does – and the two government bodies have differing approaches to reviewing manufacturing sites.
