Crawford was reluctant to openly seek more money or expanded oversight authority at the July appropriations hearing. He said
he is "open to discussion" of such proposals, but that FDA's Drug Safety Oversight Board and Drug Watch safety information
Web site can best address public demands for more drug safety information.
Forging a Critical Path
A related challenge for Crawford is to counter fears in the research community that drug safety concerns may prompt FDA to
require longer, larger clinical studies. At the July IOM committee meeting, OND director John Jenkins described the "unintended
consequences" of such a slow-down: A demand for larger trials could prompt sponsors to cancel drug development programs altogether,
and longer studies could delay access to potentially valuable treatments. But members of Congress on both sides of the aisle
don't buy concerns about development costs—especially when they see pharma companies enjoying apparently huge profits.
Meanwhile, continued focus on drug safety has put FDA's Critical Path initiative on the back burner. After issuing an initial
report more than a year ago, FDA is still promising to publish a list of opportunities for collaborative research that could
spur drug innovation. Crawford regularly mentions the importance of pursuing critical-path initiatives and now is in the position
to do so.
Proposals to expand FDA oversight authority or restructure agency operations will gain a broader hearing in coming months
as Congress prepares to tackle reauthorization of the Prescription Drug User Fee Act (PDUFA), which expires in 2007. FDA,
manufacturers, and interest groups are gearing up for the debate, which will require Crawford and his staff to articulate
agency positions on a host of hot issues:
Drug importing Crawford says FDA cannot ensure the safety and quality of products from abroad, echoing the administration's stance—and infuriating
members of Congress. Many legislators consider importing a good way to give American consumers access to lower-cost prescription
drugs and will continue to press for its legalization.
Generic biologics With patents on some $10-billion worth of branded biotech therapies expiring over the next three years, FDA is under pressure
to describe a legal and regulatory pathway for generic biopharmaceuticals. At the House appropriations hearing, Crawford said
that improved technology may facilitate characterization of complex molecules and that FDA would issue a report this fall
on follow-on proteins. Crawford's challenge is to retain incentives for developing new biotech therapies while permitting
approval of generics; legislation to clarify FDA legal authority in this area is expected.
Drug marketing Crawford has raised concerns about DTC advertising, as have leading Republicans and Democrats and health care professionals.
FDA has been issuing more warning letters on DTC ads and recently launched a process to review its DTC advertising policy.
PhRMA has issued guidelines to curb more objectionable advertising practices (see "Heading Off the DTC Regulators" ) but Congress
will press for legislation if the voluntary approach fails to address public complaints.
Next year will mark FDA's 100th anniversary, and Crawford is eyeing opportunities to highlight the agency's achievements.
The celebration will coincide with FDA's relocation to White Oak, a move that Crawford believes heralds a new chapter in FDA's
history. For the first time in decades, multiple agency operations will be housed in close proximity, making it easier to
interact and collaborate. For patients and policy makers to share this enthusiasm, the new commissioner will have to convince
them that FDA is up to the task of keeping dangerous medical products out of patients' hands, while supporting continued biomedical
Jill Wechsler is Pharmaceutical Executive's Washington correspondent.