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Exclusive Life Science Feature S peaking in whole sentences may become an everrarer practice in this, the Abbreviated Age of texts and tweets — but Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research (CDER), is someone who speaks in whole paragraphs. She is not reading from a script; she spontaneously composes succinct, lucid, and informative statements based on logic and knowledge, requiring none of the editing we usually expect with extemporaneous speech. Woodcock speaks with the perspective of a builder, not an observer. Over many years, she has helped shape and construct the agency as it is today. Consequently, she has become the most consistent, reliable voice of the FDA for most people in the life sciences industry. In general, the political and economic environment for the world's largest drug regulator has grown even more difficult since we last spoke with Woodcock for the cover story of our November 2011 issue. Broad austerity in the federal budget has largely replaced the targeted anti-regulatory assaults of two years ago, but the agency still faces the challenges of doing more with less, perhaps for many years ahead. With new responsibilities covering more regulatory and geographical territory, the FDA cannot simply add resources. Although it stands to gain new income from industry user fees, the agency carries a backlog of work and needed expenditures. Its only other option is to reorganize and redeploy the resources it has. Most of the FDA's recent assignments are mandated by law, specifically the Food and Drug Administration Safety and Innovation Act (FDASIA), the Generic Drug User Fee Act (GDUFA) and similar user-fee legislation for biosimilars, and the Drug Quality and Security Act, which amends FD&C; Section 503A to establish registration and fees for certain compounded drugs, as well as track-and-trace provisions for FDA-regulated drugs. CDER's responsibility includes the bulk of items driven by the mandates: implementing the new user-fee programs, an accelerated review process for new drugs, and pushing overall improvements in drug manufacturing and quality. To those ends, Woodcock has overseen an extensive reorganization of the drug center, including elevation of the new Office of Generic Drugs (OGD) and creation of the Office of Pharmaceutical Quality (OPQ). The changes involve shuffling existing duties and adding new ones wherever needed — sometimes to the chagrin of affected personnel. At the same time, Woodcock prefers to emphasize continuity. "We are continuing a balanced-portfolio approach across drug development, post-marketing surveillance, drug safety, scientific innovation, and controlling illegal activities," she says. "We regulate everything from drug advertising down to INDs (investigational new drugs) and first-in-human studies, and I work to make sure we have all those covered at a strong level — along with our communications office and other functions necessary for us to communicate and work with our diversity of stakeholders." GDUFA: AN OPPORTUNITY FOR BALANCE But Woodcock then proceeds to describe how the "balance" in CDER's portfolio has profoundly shifted: in this case, toward a more even-handed system for regulating the majority of prescription medicines consumed by U.S. patients — generics. "The success of the generics program had outrun its resources. We now get about a thousand ANDAs (abbreviated new drug application) every year, compared to about 200 in 1990," she says. "The staffing has increased somewhat, but not at all proportionately, and we have developed a huge stack of pending applications. So GDUFA is an opportunity to get all that back into balance." Partly because of GDUFA, but also affecting the pharma industry as a whole, CDER's reach is extending across the globe. "Our inspectional forces were always a domestically based group," says Woodcock. "But one hallmark of GDUFA is that we will now have the same regulatory scrutiny of all manufacturers, regardless of where drugs are produced around the world." For example, non-U.S. drug manufacturers, which have typically received only one inspection per plant every five years, will see the inspection rate increase to one every 18 months, the average for U.S. producers. Meanwhile, CDER has been on the educational offensive with programs to help industry streamline trials, improve clinical data quality, and share outcomes and lessons from drug development. Although relations with industry remain a mix of positive and negative, Woodcock believes a net gain has resulted from changes inside the industry itself. "On the new-drug side, the industry is emerging from a transition. It is now focusing on real innovation and less on getting me-too drugs on the market with market penetration through advertising and so forth. Under FDASIA, we have the breakthrough drug provisions which enable us to designate very promising drugs early on and facilitate their development. We also negotiated a more transparent NDA review process. Such changes are very popular in the industry." The generics sector is still in wait-and-see mode, she says. "They put their money down, they made commitments, and the February 2014 LifeScienceLeader.com 23