FDA Looks to Fill Critical Needs

Lauren Green is Associate Editor of Pharmacy Times.

PharmD graduates looking for opportunities to deploy their talents in a government setting may want to take a close look at the FDA. The agency plays the lead role in new drug and vaccine approval (think novel influenza A/H1N1), and it has been commanding a lot of attention lately in the wake of worries over recent high-profile safety issues connected with the nation’s food and drug supply chain.

Strengthening the FDA’s science base has become a top priority for many lawmakers, and the obama administration has requested a 19% funding boost for the agency in its fiscal year 2010 budget request. Part of that increase would be dedicated to safer medical Products, an initiative that targets resources at improving the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products.

Not surprisingly, the agency looks for the expertise pharmacists can provide in this enterprise. As FDA Commissioner Margaret A. Hamburg, MD, noted during her senate confirmation hearings earlier this year, “the FDA touches the life of every american, through every stage of life. The agency regulates almost one quarter of all the products americans consume, including much of the food we eat, the drugs we take to improve our health, the medical devices our doctors use, biologics like vaccines, veterinary medicines, cosmetics, and numerous other products.”

FDA Hiring Initiative

To help carry out this essential mission, the fDa recruits both pharmacists and pharmacologists; the agency currently has a hiring initiative to recruit 1300 medical and science positions to fill critical needs. Pharmacist duties range from compounding of prescriptions and other aspects of formulation and preparation of drugs, medicines, and chemicals, to the surveillance of marketed drugs for safety and efficacy. Pharmacologists may conduct research in laboratory settings or in nonlaboratory settings, performing such duties as reviewing and evaluating pharmacologic and toxicology data on new drug applications.

FDA spokesperson sandy Walsh said that many pharmacists are recruited to work in the FDA Center for Drug evaluation and Research (CDER). The majority of CDER’s pharmacists work in the office of surveillance and epidemiology (OSE), the Office of Compliance, and the Office of Generic Drugs.

Staff in the OSE use information on adverse events gleaned through company and voluntary reports to the FDA’s MedWatch program to identify drug safety concerns and recommend actions to improve product safety, including updating drug labeling; providing more information to the community; implementing or revising a risk management program; and, on rare occasions, reevaluating approval or marketing decisions. CDER also works with drug companies to reduce medication errors related to confusing labels, labeling, drug packaging, and drug names that look or sound alike.

Commissioner’s Fellowship Program

The FDA also offers a 2-year Commissioner’s Fellowship, which provides an opportunity for health professionals and scientists to receive training and experience at the agency. “We encourage both newly graduated PharmDs, as well as those with years of experience to apply,” said Walsh. “This helps contribute to the diversity of each class of fellows.” She noted that although all doctoral degree requirements (including thesis defense) must be completed before the program start date, those interested in applying for the fellowship may do so during the last semester of their program.

The Commissioner’s Fellowship starts each year in October. applications are accepted between February and April; interviews are held in July, with applicants notified of their standing in July and August. Fellows earn a competitive salary and engage in coursework combined with the development of a hypothesis-driven research project under the guidance of an FDA senior scientist. Fellows accepted to the program will train at the FDA’s new state-of-the-art White Oak campus in Silver Spring, Maryland, or at other FDA facilities.

For more information on FDA job opportunities and the Commissioner’s Fellowship, visit www.fda.gov/AboutFDA/WorkingatFDA.

For more information on the FDA Center for Drug Evaluation and Research, visit www.fda.gov/AboutFDA/CentersOffices/CDER.

FDA job postings can be found at http://jobsearch.usajobs.gov, or contact the FDA’s Rockville Center’s HelpDesk at 888-478-4340.