FDA views pharmaceutical sales forces and promotion budgets as resources for risk management.

"The drug industry spends many billions of dollars" on promotion, Center for Drug Evaluation & Research Acting Director Steven Galson, MD, told the Regulatory Affairs Professionals Society annual meeting in Baltimore Nov. 5. "If just a fraction of those resources were devoted toward safety communication, we could make huge strides."

CDER Office of Training & Communications Director Nancy Smith, PhD, concurred.

"I think...[for] drug companies, the best thing to do is work with their detail staff, because they're the ones that really talk most closely with the physicians and healthcare providers," she said.

Galson emphasized risk management as a fundamental focus for CDER heading into 2002. He delivered the annual center update to RAPS on the same day he was named to acting center director.

FDA is no longer willing to rely on labeling changes and "Dear Doctor" letters to communicate safety updates, Smith noted. Sales forces may be the best alternative, she maintained. "Other than that, I don't know of ways yet that might work."

"I really feel that most sales forces...don't want drugs to be used unsafely," Galson said. "So it's really in everyone's interest that adverse events are minimized."

In fact, Smith suggested, companies could benefit from spreading risk information by helping "good" drugs with difficult risk profiles stay on the market. For some recently withdrawn drugs, such as cisapride (Johnson & Johnson's Propulsid ) and troglitazone (Pfizer's Rezulin ), "nothing we could do in this agency could make them be used properly," she said.

FDA is already experimenting with efforts to incorporate sales forces into risk management communication efforts: Roche's updated pregnancy prevention program for Accutane (isotretinoin) relies on sales reps to enroll physicians in training (¹ Also see "Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program" - Pink Sheet, 5 November, 2001., p. 3).

Galson mentioned Accutane pregnancies as a "stark reminder" of the continuing failures of some risk management programs.

In a separate RAPS presentation, Office of Postmarketing Drug Risk Assessment Director Peter Honig, MD, highlighted some of the lessons the agency has learned from previous risk management programs (see ² Also see "CERTs Risk Management Agenda Includes Tikosyn Study, Workshops" - Pink Sheet, 12 November, 2001.).

"I really see risk management as an organizing principle for CDER," Galson told RAPS.

"It goes along with our mission...and [helps] us think about what we're doing and why we're doing it."

"I see CDER's work through a risk management lens that focuses on the public health outcomes that we all seek by looking at how our activities impact on the risk of pharmaceuticals being used in the real world," Galson continued.

"Our epidemiologic tools that we use are currently configured...such...that we're likely missing some important opportunities to intercede to improve public health," he said. "We need to focus more on stakeholders and what happens after drugs are approved."

The center's safety and efficacy focus needs to shift from premarketing to postmarketing, he said. "We're really truly engaged with only a fraction of our stakeholders that are a big part of this chart involving drug prescribing, dispensing and also funding."

"Input other than from our advisory committees - which is input that has a great influence on how drugs are actually used - is not universally sought," Galson said. "Some review divisions, such as antivirals, do a really excellent job of seeking this sort of input, but this is fairly unusual."

Galson joined FDA in April from the Environmental Protection Agency, where he specialized in epidemiology and risk assessment (³ Also see "Postmarketing Surveillance Will Report To Deputy Galson Under CDER Reorg." - Pink Sheet, 21 May, 2001., p. 30).

FDA is working with the pharmaceutical industry on developing risk management proposals.

The Pharmaceutical Research and Manufacturers of America and FDA have formed a "toolkit working group" ("The Pink Sheet" Oct. 29, p. 15).

The group's goal is to discuss the pros and cons of existing risk management tools, such as restricted distribution schemes and MedGuides, and to try to develop new ones, Galson explained.

"We know the current healthcare system cannot support a wild proliferation of restricted distribution schemes, each with a separate set of rules," he said. It is important to examine existing tools' "effectiveness and increasing burden on [the] system." The group has met once and plans more meetings.

In addition, PhRMA and FDA are collaborating with academia on risk management studies being carried out by the Centers for Education & Research on Therapeutics, Galson noted.

An April risk communication workshop was cosponsored by CERTs, FDA, PhRMA, and the Agency for Healthcare Research & Quality. That workshop created the groundwork for FDA/PhRMA's toolkit collaboration.

Ideas discussed at the workshop included the use of drug promotions to highlight risk information (⁴ Also see "IMS Risk Management Tool Targets "High Risk" MDs: CERTs Conference" - Pink Sheet, 21 May, 2001., p. 28).

One result of the workshop is a model project at Carnegie Mellon University, which applies "quantitative analysis to try to better understand how to communicate public health messages," Galson said.

Four follow-up CERTs workshops are planned for the summer and fall of 2002.

CDER is also working with PhRMA on a hepatotoxicity working group.

CDER is planning to examine the NDAs of drugs withdrawn due to liver toxicity to see whether adverse events could have been foreseen; the project follows up on an FDA/PhRMA/American Association for the Study of Liver Diseases hepatotoxicity workshop in February (⁵ Also see "Pediatric Research Rule Lawsuit To Proceed Following Court Decision" - Pink Sheet, 5 November, 2001., p. 11).

FDA is also participating in an HHS patient safety task force. "The goal of this group is to reduce patient risks by promoting partnerships between federal agencies, private sector organizations and states," with a focus on adverse drug reactions, medication errors and product problems, Galson explained.

Another CDER project involves combining data systems among different agencies in an attempt to reduce adverse events.

The data will be examined by OPDRA, which is being renamed the Office of Drug Safety and moved to operate as part of the center director's office.

The Office of Drug Safety will have its own external advisory committee, Galson announced.

FDA is currently "forming an advisory committee on drug safety and risk management," Galson said. The committee is slated to begin meeting in 2002.

CDER has a roster for the committee, Galson indicated. The committee "assembles a superb group of outside experts who we are going to...be able to rely on in the coming years to give us input," he said.

The committee charter is awaiting approval within CDER. The group is expected to meet several times a year to discuss general risk management and drug safety issues, including recommendations for specific drugs when appropriate.

The agency plans to develop a risk management "white paper" and a proposed "action plan" by next spring. The plan will "lay out steps that we're going to follow in the next year in CDER," Galson said.

CDER wants to create "a guidance that allows consistency and transparency in risk management decisions, both pre-approval and post-approval," the FDAer stressed.

A central drug labeling database - "Daily Med" - is also in the works, and will "totally transform over the next few years how we in the healthcare community manage the information in our approved labeling," Galson said.

Compiled in conjunction with the National Library of Medicine and the Veterans Administration, the database will allow quick access to the most recent labeling information.

FDA Sees Risk Management Role For Sales Forces; Drug Safety Cmte. Coming

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