New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.

One of the more significant measures in the new law is the provision that authorizes for the first time the collection of user fees on applications for generic drug and biosimilars. The measure is expected to accelerate the approval process for lower-cost generic drugs, while funding a new approval pathway for biosimilars.

For your reference, here’s a roundup of legal advisories on the new law (we will add additional commentary as it comes in):

Congress Passes FDA User Fee Legislation (Skadden, Arps, Slate, Meagher & Flom LLP):

“Among other things, the 2010 Patient Protection and Affordable Care Act created an abbreviated approval pathway for biological products that are demonstrated to be ‘biosimilar’ to, or interchangeable with, an FDA-licensed biological product. Through the Biosimilars User Fee Act (BsUFA), FDASIA now authorizes the collection of user fees for biosimilar applications, products, establishments and certain biosimilar product development activities. These fees are set by reference to the fees applicable to prescription drug products, equalizing the expected costs to the innovator biologics and the biosimilars industry.” Read on>>

President Obama Signs Bipartisan FDA User Fee Legislation (McDermott Will & Emery):

“In addition to the user fee authorization/reauthorization, the legislation addresses (or requires the FDA to address) a number of hot-button regulatory issues, including the FDA’s regulation of internet advertising for regulated products, laboratory-developed tests and mobile medical applications (among many others). However, the legislation’s most notable non-user-fee development may be the inability to reach agreement on the implementation of a federal ‘track-and-trace’ system for drugs. Faced with complex drug pedigree requirements at the state level (e.g., in California), drug manufacturers had hoped that the enactment of a federal standard and track-and-trace system would ‘preempt’ or uniformly apply instead of many differing state requirements.” Read on>>

President Signs Law Reauthorizing Drug and Device User Fees: Legislation Contains Several Important FDA Reforms (Ropes & Gray LLP):

“FDASIA gives FDA 18 months to draft regulations on the standards for admission of imported drugs, requires the Secretary to carry out drug facility inspections according to a risk-based schedule, and allows the Secretary to accept inspections performed by trusted foreign governments when establishing such schedule. It also expressly grants FDA extraterritorial federal jurisdiction for violations of the Federal Food, Drug and Cosmetic Act.” Read on>>

See also:




For related legal analysis, follow our new @FDA_Watch feed on Twitter>>