Rx User Fee Renewal, Compounding on FDA Priority List

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By Bronwyn Mixter

Dec. 14 — The top priorities for the FDA's Center for Drug Evaluation and Research (CDER) in 2016 include the reauthorization of the drug user fee programs and implementing the statutory provisions on drug compounding, Janet Woodcock, director of CDER, said Dec. 14.

Woodcock, who spoke at the FDA/CMS Summit for Biopharma Executives, said CDER also will continue to implement multiple statutes, including the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA Safety and Innovation Act of 2012 (FDASIA) and the Drug Quality and Security Act (DQSA) of 2013.

Additionally, she said CDER will be working on issuing a guidance on generic versions of abuse-deterrent formulations of opioids and establishing the FDA-European Union mutual reliance initiative for facility inspections.

“CDER has numerous priority initiatives for 2016 along with our ongoing workload,” Woodcock said.

User Fee Programs

In 2016, CDER will be working on negotiating the sixth reauthorization for the Prescription Drug User Fee Act (PDUFA), the second authorization for the Generic Drug User Fee Amendments (GDUFA) and the second authorization for the Biosimilar User Fee Act (BsUFA), Woodcock said.

Woodcock said the FDA is meeting and exceeding its goals for GDUFA and the agency is confident that it will get through the backlog of generic drug applications in the next two years. She said the biggest challenge during GDUFA I was the backlog. The user fees are paid by drugmakers and help fund the agency's operations, in addition to congressional appropriations. The agency works with industry on goals for reviews and other actions as part of its user fee discussions.

In 2016, the FDA also plans to issue additional guidance documents for biosimilars and plans to increase its educational efforts on biosimilars, Woodcock said.

“The biosimilars program is a huge amount of work,” Woodcock said. She said the agency issued a draft guidance on nonproprietary naming in August , and approved the first biosimilar drug in March .

According to the FDA, a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Woodcock said the agency received numerous comments on the naming guidance and is working on the final guidance.

Drug Compounding, Tracking

Additionally, Woodcock said CDER is continuing to put in place a regulatory structure for drug compounding.

The Drug Quality and Security Act (Pub. L. No. 113-54), which was signed into law in November 2013 , distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs and those compounders making large volumes of compounded drugs without individual prescriptions. Compounders outside the scope of traditional pharmacy practice can voluntarily register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers.

Woodcock said that so far, CDER has established the Pharmacy Compounding Advisory Committee, which has held meetings. She also said CDER has issued multiple draft and final guidances on compounding.

The agency also will continue to implement the drug track-and-trace program, which was part of the DQSA, Woodcock said. She said the agency has run into a lot of small but unanticipated difficulties with implementing that program.

Rx Opioid Abuse Epidemic

Woodcock said CDER also is working to combat the prescription opioid abuse epidemic.

Specifically, Woodcock said CDER plans to issue a guidance on generic versions of abuse-deterrent formulations. CDER already has issued a guidance for abuse-deterrent formulations of brand drugs.

Additionally, CDER plans to evaluate opioid labels and risk evaluation strategies (REMS), Woodcock said. A REMS, or risk evaluation and mitigation strategy, is sometimes imposed by the FDA on a drugmaker to ensure the risks of a product don't outweigh the benefits. CDER also will work on ensuring appropriate opioid prescribing through its Safe Use Group, she said.

Woodcock said that in 2015, the FDA spent a lot of time responding to requests for information from the House for the 21st Century Cures legislation (H.R. 6), which the House approved. She said the agency has been working with the Senate on their version of the legislation, which hasn't been introduced yet.

European Inspections

Woodcock said the FDA has made “significant” progress on the FDA-EU mutual reliance initiative.

This initiative would allow the FDA to rely more on the results of European inspections of manufacturing facilities, Woodcock said.

Woodcock said this would free up FDA resources so that the agency could concentrate on inspections in other parts of the world.

Filling 600 Vacancies

Woodcock said other priorities for CDER in 2016 include:

• reevaluating drug advertising and promotion in light of current jurisprudence around the First Amendment (the FDA has suffered court case losses in its efforts to prevent certain types of drug promotion);
• continuing to plan and build the new information technology system, called Panorama, for the drug review process and other regulatory functions;
• improving staffing (the agency has more than 600 vacancies);
• continuing the drug label improvement initiative;
• responding to outbreaks, such as the Ebola outbreak;
• developing a process and ultimate policy documents on the evaluation of a biomarker as a surrogate endpoint for accelerated approval;
• developing a strategic plan for managing drug imports;
• continuing to refine policies on personalized medicine;
• continuing to develop a policy approach for antimicrobials to treat drug-resistant organisms;
• continuing to assess the impact of the breakthough therapy program;
• advancing the patient-centered drug development program;
• refining the biomarker qualification program;
• improving the inter-center review process for combination products;
• working on the final version of the quality metrics guidance;
• working on ways to get drugs not supported by the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) studied in children; and
• developing an implementation plan and training for the pregnancy/lactation labeling rule. 

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com