“Drug Lag” Redux? Speeding Access to Already Approved Pharmaceuticals Act Would Require FDA to Take Cues from Europe

June 22, 2014

By Kurt R. Karst –      

The so-called “drug lag” – i.e., the difference (or perceived difference some might say) in drug availability between the United States and other countries – was one of myriad reasons some folks back in the early 1990s thought it was necessary to enact the Prescription Drug User Fee Act (“PDUFA”) (see here).  After all, if sponsors paid user fees to FDA, the Agency could hire additional personnel and commit to speedier reviews, thus resulting in faster drug approvals – especially vis-à-vis foreign regulatory counterparts, and the European Union in particular. 

In 2012, as Congress was considering the fifth iteration of PDUFA, FDA declared the “drug lag” reversed.  Specifically, in testimony (here at pages 22-25) before the Committee on Energy and Commerce Subcommittee on Health, FDA Commissioner Margaret A. Hamburg, M.D. stated:

Since the enactment of PDUFA, FDA has steadily increased the speed of Americans’ access to important new drugs compared to the European Union (EU) and the world as a whole.  Of the 35 innovative drugs approved in FY 2011, 24 (almost 70 percent) were approved by FDA before any other regulatory agency in the world, including the European Medicines Agency.  Of 57 novel drugs approved by both FDA and the EU between 2006 and 2010, 43 (75 percent) were approved first in the United States.

Accompanying Dr. Hamburg’s testimony was the nifty table below showing that since the late 1990s, the U.S. has regularly led the world in the first introduction of new active drug substances (i.e., novel chemical or biological substances not previously approved to treat any disease).  

U.S. Share of New Active Substances (NAS) First Launched on the World Market

A bipartisan bill introduced last week by Representatives Steve Stivers (R-OH) and Tim Ryan (D-OH), however, implies that the “drug lag” – as well as a “medical device lag” – is alive and well.  Actually, it’s not really an implication, as remarks from Reps. Stivers and Ryan say there’s a lag: “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,” and “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.”  

The answer – or, at least an answer – to the lag say the legislators is H.R. 4918, the Speeding Access to Already Approved Pharmaceuticals Act of 2014.  The two-page bill would peg FDA action to approval of a “pharmaceutical” in the European Union.  (The bill defines a “pharmaceutical” to mean a drug, a biological product, and a medical device.)  The meat of the bill is in a few lines on page two:


(1) EXPEDITED REVIEW.—Beginning not later than 90 days after a new pharmaceutical is approved for marketing in the European Union, the Secretary shall, at the request of the sponsor of the pharmaceutical, facilitate the development and expedite the review of such new pharmaceutical under section 505 or 515 of this Act or section 351 of the Public Health Service Act, as appropriate.

A particular concern underlying the introduction of the Speeding Access to Already Approved Pharmaceuticals Act of 2014 seems to revolve around new sunscreen ingredients.  According to a press release from Rep. Stivers:

Currently it can take more than a decade for a product to get approved by the FDA.  For example since 2002, eight companies have submitted new and innovative ingredients for sunscreen, but all are still languishing in the FDA’s approval process. 

There are only three FDA-approved sunscreen ingredients available in the U.S which effectively guard against the sun’s UVA rays. Europe, on the other hand, has approved seven sunscreen ingredients that help protect against these harmful UVA rays.

Interest in speeding the approval of new sunscreens has been a hot topic.  As we previously reported, legislation was introduced in the Senate and House of Representatives in March 2014 – the “Sunscreen Innovation Act,” S. 2141 and H.R. 4250 – that would amend the law to include a process for the review of potential sunscreen active ingredients.  H.R. 4250 is advancing quickly through the legislative process.  Last Friday, the Energy and Commerce Committee approved the bill and it will now move on to the House floor. 

We haven’t asked anyone from FDA what they think of the Speeding Access to Already Approved Pharmaceuticals Act of 2014 (and even if we did, we’d likely get a “no comment”), but we suspect that the Agency would not take a shine to taking direction from Europe.