FDA Head Defends Re-importation Ban

The commissioner of the Food and Drug Administration (FDA) and the Massachusetts attorney general sparred over the re-importation of prescription drugs from Canada in speeches made during a conference at Harvard Business School this weekend.

FDA Commissioner Mark B. McClellan defended his administration’s current policies against barbs from Mass. Attorney General Tom Reilly, who in a speech following McClellan’s reiterated his calls for the FDA to reconsider its policy of prohibiting re-importation.

Reilly has garnered significant media attention recently for publicly defending senior citizens who defy federal law by purchasing Canadian drugs—either through the Internet, American storefronts or across the border—at discounts ranging between 20 to 80 percent.

“They are forced to choose between putting food on the table, staying warm or paying for the medicine that they desperately need,” Reilly said in his speech. “They are forced into a situation where they have to take matters into their own hand, and that’s what they’ve done.”

Reilly said he believes laxer rules and a safe regulatory framework for re-importation are crucial first steps towards addressing healthcare prices that are “literally spiraling out of control.”

According to Reilly, the FDA already has congressional authority to establish such a framework.

“We find ways of importing food from all over the world, and keep our people safe. We can do this,” said Reilly. “We should no longer subsidize the [research and development] costs of medicine for the rest of the world.”

Reilly’s speech crescendoed into a fiery question and answer session where an unidentified representative from pharmaceutical giant Eli Lilly blasted the attorney general for suggesting dishonesty in the pharmaceutical industry.

“It’s a very high profile and provocative issue,” said Michael Fuerm, a 1997 graduate of the Business School. “It was interesting to hear the strongly diverging views and the emotions that the issue incites.”

Earlier in the day, McClellan, who holds both his M.D. and MPA from Harvard, defended the federal government’s policies.

“FDA has consistently said we can’t in good faith endorse buyer beware approaches to buying prescription drugs,” McClellan said. “Buying drugs cheaper from sources that we have neither the means nor authority to regulate is simply not the same as buying them under our safe, regulatory framework.”

McClellan argued that savings from buying Canadian drugs have been greatly exaggerated and that legislators should instead focus on Medicare prescription drug benefits for seniors and easing the availability of generic drug alternatives.

RDA Healthcare Consulting President Robert DeNoble, conference co-chair, said he thought the weekend provided the opportunity for “a good airing” of the issues surrounding healthcare costs.

“Despite the firestorm, there are some irrefutable facts. Status quo will not stand; something has to change, and that’s what Tom Reilly was saying,” DeNoble said. “[The re-importation issue] is a tactical issue serving as a surrogate for the one real issue: the cost of healthcare in America.”

The speeches were part of the Fourth Annual Alumni Healthcare Conference, a three-day event which focused on the cost and politics of healthcare.

Other notable speakers at the conference included Thomas Scully, administrator of the U.S. Department of Health and Human Services, and Scott Serota, President and CEO of Blue Cross and Blue Shield Association.

The conference also included several case studies and an interactive thought leadership session which utilized instant response technology to assess participant views on healthcare issues.