FOCUS ON SAFETY
CDER Director Janet Woodcock faces the daunting task of dealing with resource issues while reshaping the organization to handle
added postmarket safety initiatives. CDER has gained the funding to add some 400 staffers, but the task of hiring and training
a whole new cadre of reviewers and analysts will consume considerable time and energy.
Meanwhile, Woodcock is taking steps to expand drug safety monitoring and ensure safe medication use. In late February, CDER
announced a new Safety First initiative to orchestrate collaborative oversight of risk issues and avoid clashes between CDER's
new drug review offices and the Office of Surveillance and Epidemiology (OSE). A Safety First steering committee is clarifying
internal processes for managing significant safety issues, Woodcock said in a staff memo. High-level managers have been named
to every drug review office to monitor and coordinate assessment of safety issues. OSE has lead regulatory responsibility
for observational epidemiologic studies and medication error prevention, including review of proprietary names, packaging,
and container labeling. But safety officers won't get a veto over approvals, as some parties recommended.
To handle these and other new postmarket surveillance activities, CDER has expanded OSE from three to five divisions to better
monitor adverse events, weigh safety issues in applications, and review risk management plans. And OSE Director Gerald Dal
Pan heads up an expanded staff that oversees OSE management and communications and policy development.
In March, FDA launched the Risk Evaluation and Mitigation Strategies (REMS) policy authorized by FDAAA. The agency published
a list of drugs that fit the REMS criteria because they have some kind of restricted distribution system, with training or
certification requirements for prescribers and other controls on drug dispensing and patient use. Manufacturers of the 25
drugs on the list have to file REMS plans by September 21, 2008. Meanwhile, FDA is preparing guidance on REMS content and
format to clarify requirements for manufacturers developing new therapies that raise patient safety issues.
Another FDA initiative is to publicize information on emerging drug safety signals as they emerge. The same week that FDA
unveiled its REMS policy, it also announced new safety reviews related to cardio signals involving leading AIDS therapies,
GlaxoSmithKline's Ziagen (abacavir) and Bristol-Myers Squibb's Videx (didanosine). The agency also said it would conduct a
safety review of Johnson & Johnson's Regranex (becaplermin) skin gel for diabetics to determine links to cancer and death.
And FDA reported it is investigating a possible connection between suicidality and Merck's widely used asthma treatment Singulair
The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature
as an effective science-based regulatory agency. Senator Edward Kennedy (D-MA), chairman of the Senate Health, Education,
Labor, and Pensions Committee, gained approval of an amendment to the Senate budget resolution for 2009 that supports an additional
$71 million for FDA in the coming year. That would bring FDA's total budget to $2.2 billion if adopted by Congress. That fits
recommendations from agency advocates to double FDA's budget over the next five years—from $1.9 billion in 2009 to $3.7 billion
by 2013. Congress' Government Account-ability Office is developing a report on FDA resource needs, which should add more fuel
to the debate.
Even FDA Commissioner Andrew von Eschenbach has dropped the usual official inhibitions about asking publicly for more money
than his superiors have proposed. In a speech at the National Press Club in February, he acknowledged that FDA's resources
"have not kept pace" with its growing responsibilities. In a similar address at the March FDLI meeting, von Eschenbach described
FDA as a "patient in peril" because of expanding responsibilities made more complex by globalization, bioterrorism, just-in-time
delivery demands, and a continuing need for crisis control. He noted that increased FDA reliance on user fees limits the agency's
flexibility and urged "full backing" for the Reagan-Udall Foundation. "FDA needs to be stronger, bigger, and better," he said,
if it is to continue to be "the world's gold standard as a regulatory agency."
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com