Knoxville News Sentinel: Lamar Alexander pushing for FDA to regulate large compounding pharmacies

By Michael Collins

Posted on May 9, 2013

WASHINGTON — A top official with the U.S. Food and Drug Administration warned Thursday that another deadly meningitis outbreak like the one that sickened hundreds of people nationwide and killed 15 people in Tennessee last year could happen again unless the agency is allowed to regulate compounding pharmacies that mass-produce drugs and sell them across state lines.

“If, in fact, action is not taken, this will happen again,” said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. “It’s not a matter of whether. It’s a matter of when.”

Woodcock told a Senate panel that proposed legislation that would give the agency regulatory authority over compounding pharmacies is “a huge step in the right direction.”

The lack of federal oversight of compounding pharmacies was thrust into the spotlight after a Massachusetts company, the New England Compounding Center of Framingham, was identified as the source of contaminated injections that led to last year’s deadly meningitis outbreak.

Offering new insight into the breadth of the outbreak, the Centers for Disease Control and Prevention said Monday that 741 people in 20 states were sickened by the contaminated drugs and that 55 died. In Tennessee, 152 people became ill, and 15 died.

U.S. Sen. Lamar Alexander, R-Tenn., and other lawmakers have introduced legislation that Alexander says would help clarify “who is in charge and on the flagpole” for regulating compounding facilities.

The legislation would create a new category of drug facilities under federal law that would be classified as “compounding manufacturers,” which would be defined as businesses that make sterile products in advance of a prescription and sell them across state lines. Compounding manufacturers would be inspected by the FDA and also would be required to register and list their products with the agency.

State pharmacy boards would continue to oversee and regulate traditional pharmacies.

Right now, traditional compounding pharmacies, which fill special orders placed by doctors for individual patients, are overseen by state pharmacy boards, but the FDA can step in when problems arise. Yet the FDA says large compounding pharmacies that mass-produce drugs and ship them nationwide fall into a gray area in which it is not clear who has regulatory authority.

As a result, the FDA’s ability to inspect compounding pharmacies and take enforcement action has been limited and often contested in court.

Since last year’s meningitis outbreak, the FDA has inspected 57 compounding pharmacies and found serious quality concerns at 47 of them, Woodcock testified before the Senate Health, Education, Labor and Pensions Committee.

The problem areas included lack of appropriate air filtration systems, insufficient microbiological testing and other practices that create a risk of contamination, Woodcock said.

In some cases, the inspections have been delayed or hampered because investigators have been denied full access to records at some facilities, she said. In two cases, the agency had to obtain warrants to collect the sought-after records.

“Just because we are inspecting doesn’t mean we will succeed in getting them to comply,” Woodcock said.

Because of the high risk they pose, large compounding pharmacies that make products without a prescription and ship them across the country should be subjected to a greater degree of oversight, Woodcock said. The FDA should have the clear ability to collect and test samples of compounded drugs and examine records of prescriptions received, the products shipped and product-quality test results, she said.

In other testimony, spokesmen for the National Association of Boards of Pharmacy, which represents state pharmacy boards, and the American Society of Health-System Pharmacists, which represents pharmacists who work in hospitals and health clinics, told the Senate panel that the proposed legislation would address the regulatory uncertainties highlighted by the meningitis outbreak.

But David Miller of the International Academy of Compounding Pharmacists took issue with some of the definitions in the proposed law and warned that they could create more confusion and further blur the jurisdictional authority of regulators.

For example, Miller said, the bill needs to draw a clearer distinction between a pharmacy that makes compounds for individual patients and those who make compounds for widespread sale or distribution.

Miller also objected to an exemption in the law that would not hold pharmacies in hospitals and health systems accountable to the same standards as compounding centers.