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FDA regulation of pharmacies has knotty history

Associated Press Modified: October 12, 2012 at 8:16 pm •  Published: October 12, 2012
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Compounding experts, including the president of the leading compounding pharmacy trade group, believe the New England Compounding Center crossed the line into full-scale manufacturing. Indeed, the FDA had warned the company in 2006 about compounding and distributing anesthetic "for general distribution" rather than for individual prescriptions.

FDA officials said they followed up with the company after sending the warning letter but did not re-inspect it.

"They assured us they were adequately protecting patients and complying with applicable laws and regulations," Autor said. "We took some action, but it's very complicated — our ability to take action here."

A spokesman for New England Compounding Center had no comment.

FDA officials have repeatedly stressed the challenges the agency faces policing compounding operations. In fact, some former agency officials say that the FDA is hesitant to act after years of legal battles with lawyers and lobbyists for the industry.

The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the past decade and has a track record of defeating measures opposed by the industry. A 2003 provision to set up an FDA advisory committee to oversee compounders was killed by then-House Majority Leader Tom Delay, who said it would create unnecessary federal interference. Delay represented Sugar Land, Texas, the headquarters of the compounding academy.

The group's president said Friday he would "absolutely" cooperate with the FDA and Congress on new laws to prevent outbreaks.

"The behavior and actions of this one particular business resulted in the deaths of people, and that is antithetical to what pharmacists do," David Miller said. "Whatever they were doing, we have to make sure it never happens again."

But he added that New England Compounding Center appeared to be acting as a manufacturer, which is "contrary to what a compounding pharmacy is all about."

Even when the FDA has succeeded in getting legislation through Congress, it has gotten tangled up in the courts. In 1997 Congress passed an FDA-supported law that allowed the agency to regulate compounding pharmacies if they overstep certain standards for drug production, labeling and advertising. Specifically, the law said that compounding pharmacies were subject to FDA oversight if they advertised their products.

A federal appeals court sided with pharmacists and ruled that this last requirement was unconstitutional, and the Supreme Court upheld the decision in 2002. But the court did not rule on whether the other requirements in the law should stand, creating a legal limbo for regulators. Since then, different appeals courts have issued conflicting judgments on the remainder of the law, which could wind up back at the Supreme Court.

Still, some former agency lawyers say new laws are not necessary when dealing with companies that have clearly crossed the line from compounding drugs to full-blown manufacturing.

"Legislation isn't necessary here," said Sheldon Bradshaw, former FDA chief counsel during the Bush administration and now an attorney in Washington. "FDA already has all the authority they need to go after the New England Compounding Centers of the world. I'm honestly shocked by how FDA is now downplaying its authority in this regard."