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Regulatory News | 23 June 2014 | By Alexander Gaffney, RAC
When the US Food and Drug Administration (FDA) approves a drug, its primary concern is with the product's safety, efficacy and quality. But a secondary concern is what is known as "drug lag"—the time between when a product was first approved for use elsewhere in the world and when it was approved in the US.
The issue of drug lag was once a major concern in the US, which largely lagged behind the EU in drug approvals, but has largely fallen into obscurity as systemic changes to the US regulatory system have left FDA better suited to approve drugs more quickly. The Prescription Drug User Fee Act (PDUFA), for example, allowed FDA to hire more reviewers using industry-paid money in return for review deadlines. And new review programs, such as accelerated approval, priority review designation and fast-track designation, have all allowed FDA to approve drugs faster than ever.
And with those improvements in place, many drug companies have come to see the US regulatory environment as both quick and relatively predictable, resulting in increasing numbers of first filings.
As of 2013, FDA said that 74% percent of NMEs approved in 2013 were approved in the US before anywhere else in the world—a record high according to data compiled by FDA Law Blog.
That percentage "reflects CDER's willingness to exercise regulatory flexibility and creative approaches to help industry meet our standards—without lowering them—so that we may continue to provide medicines to patients in need," the regulator added.
Previous reports have also indicated that FDA approves drugs more quickly than its EU and Canadian counterparts. According to a report published in the New England Journal of Medicine (NEJM), between 2001 and 2010, FDA approved 225 new drugs, with each product taking an average of 303 days to approve. Meanwhile, the European Medicines Agency (EMA) and Health Canada respectively approved just 186 and 99 drugs during that time, taking on average 366 days (EMA) and 352 days (Health Canada) to review the drugs. (More from Focus)
But not all parties appear to be content with the progress made so far—if they even recognize it.
On 19 June 2014, Rep. Steve Stivers (R-OH) introduced HR 4918, the Speeding Access to Already Approved Pharmaceuticals Actof 2014, which would require US regulators to expedite the review of any drug already approved in the EU by EMA.
Based on Stivers' remarks, the congressman believes any drug lag is unacceptable.
"Unfortunately, FDA’s red tape causes delays of up to several years in approval for life-saving and life-changing medical treatments,” Stivers said in a statement. “These delays result in unnecessary death and suffering of American patients. This bill will help speed US approval of drugs and medical devices deemed safe and effective by European Authorities."
Any drug approved in the EU would be eligible for a 90-day review in the US, Stivers said.
Curiously, Stivers cited the example of sunscreen ingredients that have been approved in the EU for years—and in at least two cases more than a decade—as being indicative of drug lag. However, the EU regulates sunscreen ingredients as cosmetics—not as drugs—and are thus held to much laxer standards for approval. House legislators are currently moving forward with legislation, the Sunscreen Innovation Act, that would require FDA to review those ingredients more quickly, however.
The legislation might also have the opposite effect as intended and encourage drug lag for some companies. If a company believes that it could receive EMA approval at or around the same time as FDA, the legislation could cause the company to file first in the EU, knowing that once it obtained EMA approval it could obtain FDA approval within three months. That would likely save the company a great deal of time—and money—dealing with FDA, as most review cycles take between nine and 12 months.
It remains unclear, however, how FDA would "facilitate the development" of these types of drugs, and how it would obtain the resources necessary to review those drugs in just 90 days— an extraordinarily fast review time almost never seen for new drugs.
The legislation also applies to medical devices, Stivers said. "This bill will help speed U.S. approval of drugs and medical devices deemed safe and effective by European Authorities," his office wrote.
On one hand, that appeal makes sense: Devices are approved much more quickly in the EU than in the US.
However, that speed is due in part to major differences in regulatory requirements. In the US, devices must generally be able to show that they are both safe and effective, either by showing that they are similar to a predicate device or existing standards (Class II, "moderate risk" devices) or by undergoing an extensive premarket review process (Class III, "high risk" devices).
By contrast, the EU doesn't regulate medical devices with a single regulator, but instead uses a decentralized system of state regulatory bodies and third-party CE-marking organizations (known as notified bodies) to oversee the safety and efficacy of devices.
FDA regulators reportedly view the EU's medical device regulatory system as "ineffective" and resulting in "unsafe" products, so it's unclear how FDA would approve devices more quickly without either asking for considerably more data from companies or eliminating or substantially reducing its evidentiary requirements.
In the meantime, FDA has touted new changes under the Medical Device User Fee Act (MDUFA), a user fee program modeled after PDUFA, as potentially reducing device approval times and device lag.
As of 23 June 2014, the legislation only has one co-sponsor, Rep. Tim Ryan (D-OH). The bill has been referred to the House Energy and Commerce Committee for further study.
Speeding Access to Already Approved Pharmaceuticals Act
FDA Law Blog Coverage
Tags: Drug Lag, Legislation, Bill, Sunscreen