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Inside Health Policy – With FDA Bill Signed, Agency Assumes Slew of New Powers, Mandates

Inside Health Policy – With FDA Bill Signed, Agency Assumes Slew of New Powers, Mandates


President Barack Obama’s signing Monday (July 9) of the FDA Safety and Innovation Act officially sets in motion implementation of the law that reauthorizes and establishes product user fees, and mandates several key reforms.

 With the bill’s enactment, reforms such as tools to prevent drug shortages and antibiotic exclusivity incentives are immediately available, but the agency must also develop several policies in the coming years, such as questions ranging from social media regulation to antibiotic development.

While the user fee programs become effective Oct. 1 — the beginning of the fiscal year — FDA is already laying the groundwork for a new review program for new molecular entities and biologics. The agency also started clearing inactive applications in the generic drug backlog ahead of fees that will be charged to pending abbreviated new drug applications at the beginning of the fiscal year.

A provision expediting FDA’s response time to citizen petitions, a measure expected to pay for the cost of the bill by bringing generic drugs to market more quickly, will go into effect immediately. Another generic drug provision that extends the period of time first filing generic drug firms have to obtain approval without forfeiting their 180-day exclusivity period also starts with enactment.

Additional antibiotic exclusivity granted under the Generating Antibiotic Incentives Now section of the law will start immediately, but FDA will have to produce guidance on clinical trials and pathogen-focused development.

The ability to study drugs associated with a specific pathogen across several sites of infection is a topic that some industry stakeholders hope will be addressed in the required guidances. For example, developers could study a drug in pneumonia patients and extrapolate the data for use on another site of infection. FDA will have to address such complicated antibiotic development issues moving forward, said Allan Coukell, director of medical programs at the Pew Health Group.

“Scientifically it’s very important that we can have confidence that the drugs are effective” in the manner they’re being used, he said. Each year, FDA must revise at least three guidance documents related to clinical trials. Separately, the agency will have to issue guidance on pathogen-focused antibiotic development by June 2013 and will have to assess the product incentives in five years.

In the device arena, several reforms go into effect immediately, such as changes to the de novo pathway and FDA’s ability to request postmarket studies that start within 15 months. Janet Trunzo, Advanced Medical Technology Association senior executive vice president for technology regulatory affairs, said the industry group will be monitoring the long-negotiated medical device user fee commitment letter. Device center Director Jeffrey Shuren has said he will start ramping up staff in anticipation of the new program.

Trunzo said many components of FDA’s 510(k) reform plan will have to be updated according to the law. For example, she said she expects the finalized de novo guidance to incorporate changes from the law, which says companies no longer have to apply for and be rejected from the 510(k) clearance process before being considered through the de novo pathway. FDA had issued guidance intended to streamline access to de novo, but needed congressional approval to forgo the 510(k) submission to gain access to the pathway, which is for low- and moderate-risk devices with no predicates.

FDA will also have to withdraw guidance on when device modifications warrant a new 510(k) submission. “We will be monitoring everything that impacts device regulation,” Trunzo said of FDA’s implementation of the device reforms.

Further, FDA last week issued the Unique Device Identifier rule fulfilling a FDASIA requirement that the agency release the long-awaited regulation by the end of the year, although the law also sets forth a timeframe for finalizing it.

Many of the reports, regulations and guidance requirements — such as social media guidance, a report on small businesses and an integrated management plan — will come due in a year or two. But some are expected in the coming months.

Conflict-of-interest provisions requiring ramped up recruitment and financial disclosure of conflicted advisory committee members start at the beginning of the fiscal year. Within six months, FDA must release guidance on abuse-deterrent products, an issue that the agency has been grappling with as it has proved challenging to define standards for these products. Within 60 days, HHS must hold a public meeting on the Drug Enforcement Administration scheduling of hydrocodone, an issue that garnered controversy late in the legislative process because many stakeholders feared it would put a burden on patients who need the drugs. There is also a provision to prevent FDA from further delaying enforcement of its sunscreen rule, which goes into effect in December for large companies. Plus, as a result of the new law, starting in 180 days, companies can file a request for certification of a medical gas.

While the president signed the bill with no fanfare, the House Energy and Commerce Committee used the new law to tout the committee’s jobs agenda.

“The FDA Safety and Innovation Act will make a real difference in the lives of patients and provide much needed support for our nation’s job creators,” Committee Chair Fred Upton (R-MI) said in a statement. “This law will improve predictability, consistency, transparency, and efficiency of FDA regulations and will help patients get access to new treatments more quickly. These important reforms will help us not only keep jobs in Michigan and all across America, but also to create new ones. This is an important bipartisan accomplishment, and I congratulate all of my colleagues who helped get the bill across the finish line.”