Two prominent health care policy scholars debated the policies of the Food and Drug Administration and pharmaceutical companies at the Heller School for Social Policy and Management's fifth annual Zinner Distinguished Lecture Series on April 12.Titled "Promoting and Protecting the Public's Health: Reconciling the Perspectives of Patients, Payers, Government and Industry," the debate centered around issues involving the detection of harmful side effects of drugs, both before and after they enter the market, as well as the impacts of the pharmaceutical companies' advertising spending and U.S.'s free-market regulatory model on the drug consumers.

Held in Rapaporte Treasure Hall, the debate was moderated by Stuart Altman, professor of national health policy at the Heller School. The panelists included Jerry Avorn, M.D., a professor of medicine at Harvard Medical School, and Kenneth I. Kaitin, Ph.D, director of the Tufts Center for the Study of Drug Development.

Avorn suggested that the FDA implement a longer and more cautious drug approval process that would better identify the side effects of drugs before they enter the market.

He also said that drug trials should incorporate larger numbers of patients, advocating for a more effective system to detect side effects not detected in drug trials. Criticizing the FDA for only initiating half of post-approval drug studies, Avorn called for the FDA to conduct more extensive research to identify and evaluate the risks of drugs already on the market.

"I'm unhappy with the way the FDA operates [and] the FDA's capacity to get on top of drug problems," he said, adding as an example that between 2.5 and 3 percent of approved drugs are taken off the market because they are later found to be unsafe.

Kaitin agreed, but cautioned against slowing down approval processes to the detriment of innovation.

"My worry is that the crisis mentality may lead us down a road of requirements or regulations on the industry that will impede the flow of new products," Kaitin said.

Avorn's criticism was not limited to the FDA.

He also argued that pharmaceutical companies do not allocate their funds appropriately, dedicating only 11 percent of their budgets to research and developmen because, he said, the pharmaceutical industry has become a "vast marketing machine."

But those advertisements do some public good, Kaitin said, praising their benefits.

"There is a drug under-usage problem among Americans," he said, adding that advertisements may combat that trend.

"More people are seeking prescriptions that they wouldn't have before," he said. "People who see these ads stay on their drugs more."

When asked why the American market can price drugs higher than can any other country, Kaitin said that "the rest of the world has price control on prescription drugs," but the U.S. offers pharmaceutical companies an open market in which they can set prices and have greater freedom to develop new drugs.

"Controls hinder innovation ... the U.S. is the largest pharmaceutical marketplace in the world," Kaitlin said.

Kaitin also disagreed with Avorn's view that pharmaceutical companies do not devote sufficient resources to develop new drugs.

According to Avorn, most new drugs "are coming from university laboratories and biotech centers," not pharmaceutical companies.

But Kaitin said that a great deal of research done in the biotech sector is actually funded by large pharmaceuticals.