In certain cases, the Food and Drug Administration (FDA) still needs help in "thinking through" how to use its new drug regulatory tool, Risk Evaluation and Mitigation Strategy (REMS), Joshua Sharfstein, MD, told an audience of 200 students and faculty at the University of Maryland School of Pharmacy.
Sharfstein, FDA's principal deputy commissioner, delivered the School's 2010 Francis S. Balassone Memorial Lecture, following the official opening of its $62 million Pharmacy Hall on Oct. 5.
REMS has expanded FDA's authority since 2007 to require manufacturers to ensure that benefits of a drug or biological product outweigh its risks, but the tool is still a work in progress, Sharfstein indicated.
In his lecture, he presented a history of an evolving role of FDA in drug regulation, then suggested issues and areas of research in which graduating pharmacists and faculty at the School can lend a hand to the agency. He challenged them, "Given we have this incredible new tool [REMS], how do we learn to do it well?"
The agency has gradually extended its reach one major law at a time, said Sharfstein, including the Food and Drug Administration Amendments Act of 2007 authorizing the FDA to use REMS.
"At this critical moment," said Sharfstein, when the agency has better tools for evaluating medications and an improved regulatory climate, public health and the nation's health care system "getting closer and closer together."
Sharfstein said in terms of pharmacy sciences, there has been far more invested in basic (discovery) science and risk assessment than in regulatory science and benefits assessments.
"Public health assessment of benefits is a whole area that needs to be better understood, while risk assessment is a more common research thread," he said.
He said the agency wants more help from the School's research scientists in developing better basic science tests, citing the example of a new FDA $1.1 million contract for the School to study the "switchability" of federally approved generic and brand anti-epileptic drugs.
He recognized the significant value of the after-market studies by the School's Department of Pharmaceutical Health Services Research on medication use by select populations."I encourage people to do more of this kind of work in the safety and benefits of medications after market, " he continued.
The University of Maryland School of Pharmacy, in addition to helping educate the next generation of pharmacists, also conducts original research in drug discovery, drug metabolism, drug transporters, pharmacokinetics (fate of medications in the body), and clinical sciences.He said the FDA also needs more information to better track the drug supply in the United States. "There are definite gray areas," he said, cases such as stolen truckloads of drugs that can show up in the system after they are expired.
Whereas a 1938 federal law defined a federal role to help to make sure drugs are safe, and 1962 statutes for the first time required pre-market testing, the 2007 amendments "moved FDA further along the spectrum," he said.
"Now we can act to put restrictions on drugs to assess whether their benefits outweigh their risks. We can do this before approval or after," explained Sharfstein.
Although the regulatory tool is still in its infancy, the FDA has approved 146 medications under REMS, and its added flexibility helped FDA resolve complex, controversial cases such as restricting health care professionals' use of the diabetes drug rosiglitazone in response to data suggesting that an elevated risk of cardiovascular events.
The Balassone lecture is held annually in honor of Francis S. Balassone (1915-1972), a distinguished pharmacy leader who collaborated with the School of Pharmacy to develop the University of Maryland professional pharmacy program.
Sharfstein is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined residency program in pediatrics at Boston Children's Hospital and Boston Medical Center, and a 2001 graduate of the fellowship in general pediatrics at the Boston University School of Medicine. From December 2005 through March 2009, Sharfstein was the commissioner of health for the city of Baltimore.