Regulating Compounding Pharmacies

Prof. Kevin Outterson offers his expertise to Gov. Patrick’s special commission and beyond

kevin outterson

Associate Professor Kevin Outterson (second from left) participates in Governor Deval Patrick's press conference announcing new legislation regarding compounding pharmacies.

This fall a fatal fungal meningitis outbreak caused by tainted steroids from the New England Compounding Center (NECC) killed 37 patients and infected 590 others. Questions arose: How were the drugs tainted? Where do our drugs come from? And, even, what is a compounding center?

Because of his extensive research on global pharmaceutical markets, Associate Professor of Law Kevin Outterson served as an expert witness for an unrelated case about compounding pharmaceuticals in Florida over the summer. Media outlets—including Scientific American, The New York Times, The Los Angeles Times, Forbes and NPR, among others—began turning to him for answers when the fall outbreak hit.

On a policy level, Gov. Deval Patrick recently appointed Outterson to the Special Commission on Compounding Pharmacies, which will examine the outbreak and the NECC. Among those on the commission are state senators, heads of legislative committees and a few outside experts. Outterson is the sole law professor.

“We’re trying to come up with the reasonable set of recommendations about how to improve the regulation of these facilities,” Outterson says.

Members have met weekly since November to examine best practices in other states, explore potential changes to laws, and fill gaps between state and federal regulation. Outterson notes that the commission is looking at Massachusetts’ facilities producing compounding drugs, as well as compounding facilities in other states that sell products in the Bay State.

“We need to protect consumers, but it is inefficient for Massachusetts to try and regulate Tennessee compounders, nor is it easy for Tennessee hospitals try to think about regulating Massachusetts compounders,” Outterson says. Federal regulation must cover the gap between the states.

Outterson discusses federal regulation of compounders in his article, “Regulating Compounding Pharmacies after NECC,” published in The New England Journal of Medicine a week before the commission was brought together. In the article, he notes the Supreme Court’s decision in Thompson v. Western States Medical Center (2002), which declared a 1997 statute unconstitutional because it banned compounding pharmacies from advertising their products. When remanded to the Ninth Circuit, the entire statute, which would have provided other regulations for compounding pharmacies, was thrown out.

“Under the 1997 law, one provision said that if a pharmacy ships more than five percent of its products across state lines, more aggressive regulations applied. NECC would have been regulated by this provision, were it not for the Supreme Court’s decision,” Outterson says. “If the statute had not been thrown out by the Supreme Court, then the NECC could not have flourished as it did with inadequate regulation.”

The commission is due to provide its recommendations to the governor by Dec. 31.

In the meantime, Outterson has a full plate of teaching at the law school. He also serves on similar commissions at the CDC and the Brookings-FDA task force for his other research interest concerning antibiotic resistance.

“I think you’re a better teacher if you have some continuing practical interaction with real legal disputes,” Outterson says. “Being on these groups, I'm at the table with the policy makers who write the rules."

Additionally, Outterson posts two to three times a week on his coauthored blog, The Incidental Economist, one of the leading health economics blogs in the U.S. He notes that many law professors blog to develop ideas that eventually result in longer pieces of scholarship.

“Reading the academic blogs helps you to flesh out your arguments in advance; you get a better result,” Outterson says. “You get interaction months before you’ve written that piece, which I think helps you from making fundamental mistakes and sharpens your work as you go along.”

While Outterson was a practicing attorney, he started gravitating to health care law because of the interesting clients and fascinating problems.

“What I like in health care law is that it’s a very personal, human thing,” Outterson says. “Every year the class is filled with interesting stories. Everyone has interaction with the health care system, either themselves or their relatives.”

Reported by Elyssa Sternberg
December 19, 2012

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