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Drug safety, medical advances may benefit from proposed four-part drug approval plan
Former FDA commissioner candidate questioned FDA's ability to deliver safe, effective drugs.
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Drugs that help save lives and alleviate symptoms of a multitude of illnesses may get to market faster if the FDA adopts a more rational drug approval system, according to one expert's proposal.
In the New England Journal of Medicine, Alastair J.J. Wood, MD, suggested a 4-step plan to radically change the FDA drug approval process. He said it would help bring safer drugs to market and provide drug developers with realistic incentives for conducting investigational studies and completing phase 4 regulatory commitments.
"I'd like to see us move forward because I think it's an important public health issue," Wood told Orthopedics Today. "This new plan would keep us from having to repeat the COX-2 problems, which I think has been painful for everybody involved - patients, companies, regulators."
If adopted, such a plan might encourage development of drug therapies for conditions like osteoarthritis and Alzheimer's disease, for which no preventive drugs currently exist.
Wood was assistant vice chancellor for research, professor of medicine and pharmacology at Vanderbilt University, Nashville, Tenn. He is now managing director of Symphony Capital, a private equity firm. Last year, he chaired the FDA committee that reviewed COX-2 inhibitor safety.
Summarizing his reform plan, Wood said, "What we're trying to achieve ... is getting long-term safety data, which we don't get right now; getting head-to-head comparisons of drugs, of which we have almost none right now; getting people to complete commitments that they make to the FDA that they'll do after they get approval of a drug, particularly when they get accelerated approval."
His other proposed goals: Ensure conversion of surrogate and biologic marker end points to clinically meaningful ones, and offer incentives to develop drugs with high commercial risk. Under the current system, developing a drug similar to one on the market provides the same period of exclusivity as it does to those who develop, for example, the first drug to prevent osteoarthritis, he said.
In an example, Wood cited the highly marketed "purple pill" Nexium, a medication that is similar in formulation to the original purple pill. That drug was given the same period of exclusivity as a totally novel drug to cure, for example, osteoarthritis. "We need drugs ... to prevent Alzheimer's, for instance. We don't know how to do that. We don't even know, perhaps, the targets very well yet and we don't give these people any greater exclusivity than that granted for reformulation of an already approved drug."
Wood suggested ways to implement such change. "Organized medicine itself needs to demand it," he said. "If we start to expect, look, demand the drugs that have truly novel mechanisms of action or truly incremental, clinically meaningful benefits over existing therapies, then drug companies are going to try to develop these."
Action must begin within the next 24 months, since the prescription drug users fee act or PDUFA is up for renewal in 2007. It poses a real window of opportunity for change, Wood said.
"Motivating people and incentivizing people to demonstrate long-term safety is clearly important and is likely to get results." Had Wood's proposal been in place when initial COX-2 drugs studies, particularly for Vioxx, raised cardiac safety issues, the FDA could have made Merck complete a cardiovascular safety study within 12 months, saying "If you don't, you'll lose your exclusivity."
For more information:
- Wood AJJ. A proposal for radical changes in the drug-approval process. N Engl J Med. 2006;355(6):618-23.