As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet
Woodcock has built a robust and modern drug regulatory system. She implemented the drug user fee program, which was enacted
by Congress in 1992, to eliminate a perceived "drug lag" problem; elevated the role of drug safety; established an effective
program to make less-costly generic drugs available to consumers; and reorganized CDER into a high-performing organization—something
that makes her most proud. Despite burgeoning demands, CDER is able to get out new and generic drugs, to expand oversight
of marketed medicines, to issue hundreds of guidances, and to harmonize policies internationally. "As drug regulators," she
says, "we're still in the forefront."
Janet Woodcock, MD
In this high-profile job, Woodcock has been questioned by members of Congress about safeguarding patients in clinical trials,
permitting unsafe drugs into the country, and blocking patients from needed therapies. Increased public focus on drug safety
was inevitable, she says, and a logical outgrowth of successful drug development. When there were few treatments for HIV,
for example, patients just wanted more therapies, even those with safety problems. As soon as more options appeared, people
wanted to know how safe they were, which to use first, and how to take them. And that raises the comparative effectiveness
question. "As we have more drugs available," she notes, "we want to learn more about them."
Woodcock considers establishing a system for evaluating generic drugs an important success. Prior to the Hatch-Waxman Act,
generic drugs were notoriously of low quality, and people didn't want to use them, she recalls. "So we had to say that not
only were they interchangeable from a technical viewpoint, but they were of the same high quality as the innovator drug."
Unfortunately, FDA is a victim of its own success, now receiving so many applications for generics that it can't keep up.
Generic drug user fees will help, she says, "and this time everyone's serious about it."
Woodcock feels that pharma was shortsighted back in the '90s for failing to recognize the potentially serious impact of healthcare
cost-control efforts. Although medicines account for a small fraction of health spending, drug prices were rising quickly
and received a lot of attention, she notes. The result was that the golden pharma industry came to be viewed similarly to
the tobacco companies. "Part of it was the out-of-pocket costs of medicine, and part of it was the behavior of some members
of the industry—and extremely aggressive direct-to-consumer advertising and illegal promotions didn't help." By not cleaning
up its act earlier, "[pharma's] reputational problem became much worse than it needed to be," Woodcock observes.
Pharma is facing a crisis, she says, with tighter cash flow due to patent expiries, pipelines with fewer new drugs, and a
healthcare system that resists buying their products. "Industry is scrambling to figure out how to survive as R&D enterprises
in this new environment." Yet Woodcock is optimistic that new discoveries in genomics and other sciences will spur another
wave of drug development, as it did 30 years ago. The next decade will be the age of diagnostics, she predicts, because diagnosis
will be key to treatment. And the coming generation of drugs will be more targeted. FDA and industry will develop new tools
to better understand disease, and sponsors won't take compounds forward unless there is a high probability of success. – Jill Wechsler