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WSJ – FDA Urged to Speed Approval of Drugs

WSJ – FDA Urged to Speed Approval of Drugs


A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.

The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called “special medical use” approvals.

The advisory report gave few details of what new laws or regulations might be required to limit a new drug’s use to such populations. Historically, the FDA doesn’t attempt to police how doctors use drugs, though companies’ marketing is restricted to the conditions specified on the label.

The FDA since the 1990s has employed what it terms “accelerated approval” of certain drugs, first in treating AIDS and more recently in treating cancer. In doing so, the agency has allowed assessing relatively quick measures, such as the time until a tumor resumes growing, to approve certain drugs. The council said in its report that the FDA “could expand its use of accelerated approval to address more types of serious diseases with unmet medical need.”

Of 35 medicines termed “innovative” by the FDA and approved during fiscal 2011, 16 received some sort of shortened review or expedited approval.

The report, released weeks before the election, comes after Republicans and businesses have criticized the Obama administration for stifling innovation through heavier regulations since he took office.

Top officials at the FDA have said they are working to cut red tape for drug approvals, and pointed toward Tuesday’s report as a big step in that direction.

“American researchers and companies should be able to accelerate the development of safe and effective drugs while also strengthening the U.S. economy,” said Eric Lander, co-chairman of the president’s council and director of the MIT-Harvard Broad Institute in Cambridge, Mass.

Christine Cassel, president of the American Board of Internal Medicine, said a morbidly obese patient “with a really life-threatening condition might be willing to try a drug with far greater side effects.”

But, she said, the FDA now can’t safely approve that drug for fear that a far wider population might be exposed. The rules proposed would change that by approving new drugs but restricting them to a very limited patient population.

Similarly, a patient with a life-threatening septic infection might be willing to receive an antibiotic with severe side effects, even such as kidney damage or hearing loss, she said.

Ellen Sigal, chairwoman of Friends of Cancer Research, lauded the group’s goals and the effort to “help deliver promising new medications to patients facing severe illness, while protecting the general public from potential hazards.”

Thomas J. Moore, director of the drug-safety publication QuarterWatch, said the report “recommends exposing more patients earlier to new drugs that have not yet undergone complete testing” and called that a “health gamble.” He added, though, that the report offered some “good ideas about how to test drugs more efficiently.”

Overall, the number of new drugs approved by the FDA over the past two decades has tended to rise and fall with the number of new-drug applications it has received. While research-and-development expenditures by the pharmaceutical industry have grown exponentially over more than three decades, new-drug approvals peaked in the mid-1990s and have been relatively constant since then.