Senate approves FDA role for specialty pharmacies

WASHINGTON — — The Food and Drug Administration would play a broader role in regulating specialty pharmacies, such as the one responsible for last year's deadly outbreak of meningitis, under legislation approved by Congress on Monday and expected to be signed by President Barack Obama.

Lawmakers have been negotiating for months over a bill to crack down on so-called compounding pharmacies after a Massachusetts firm distributed contaminated steroids that led to the outbreak last year. Sixty-four people who received the steroid injections died, including three in Maryland, and hundreds more were injured.


Some advocates hailed the Senate's final passage of the Drug Quality and Security Act as an important step in clarifying federal authority to inspect and regulate the drug makers' facilities. Others said it watered down provisions that had been included in an earlier version approved by the Senate.

The bill "will help protect lives … by ensuring that prescription drugs are safe, effective and of the highest quality," said Allan Coukell, who oversees medical programs at the Pew Charitable Trusts.


Critics said the proposal doesn't clearly delineate which types of facilities will be regulated by the FDA and which would remain under state oversight. Instead, the measure allows large compounding pharmacies to voluntarily identify themselves as "outsourcing facilities," a classification that would trigger FDA regulation.

"If the goal of this legislation is to prevent another [outbreak], which has been stated many times over, then the American public must know that this bill will not accomplish that goal," David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, said in a statement.

"A voluntary category of outsourcing facilities is not the answer," he said.

Compounding pharmacies have traditionally been small operations that tailor therapies for specific patients, such as by removing an ingredient from a drug if a patient is allergic to it. There has been little desire in Washington to change the rules for those facilities.

But compounding has increasingly been used to make drugs that are supplied to physicians and hospitals for a much wider distribution, often across state lines. Officials at the Silver Spring-based FDA have said that conflicting federal court decisions have limited the agency's ability to regulate those larger compounding facilities and the drugs they produce.

Supporters said that, while voluntary, designation as "FDA-regulated" could become a sought-after stamp of approval for both makers and buyers of compound drugs. They also noted the remarkable bipartisanship under which the bill advanced through an otherwise divided Congress.

The Senate approved the bill by a unanimous voice vote Monday.

The legislation also sets up a system that will make it easier for regulators to track drugs as they move through the marketplace. The measure is an effort to confront concerns about counterfeit drugs.


"The legislation we passed will save lives," Sen. Barbara A. Mikulski, a Maryland Democrat and member of the Senate's Health, Education, Labor and Pensions Committee said in a statement. "It is bipartisan, achievable, affordable and doable."

Maryland had aggressive laws in place prior to last year's outbreak, but the General Assembly approved a more comprehensive law this year. Those new regulations require pharmacies that make injectable drugs to receive additional permits.

The new state law also requires out-of-state compounding pharmacies making drugs that aren't tailored for a specific patient to get a waiver from Maryland's pharmacy board before selling their product in the state.