As meningitis hearings start, Marsha Blackburn urges caution

WASHINGTON — Rep. Marsha Blackburn says Congress needs to find out how meningitis-causing steroid drugs got through the nation’s pharmaceutical safety net but should refrain from attacking all compounding pharmacies.

Blackburn, R-Brentwood, made those comments in an interview as she looked forward to the start of congressional hearings Wednesday on the contaminated steroids from the New England Compounding Center in Framingham, Mass., that are blamed for at least 438 illnesses and 32 deaths from fungal meningitis nationwide. In Tennessee, there have been 13 deaths, the most of any state.

The Oversight and Investigations Subcommittee of the House Energy and Commerce will hear from witnesses that include Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, and Barry Cadden, NECC owner. The subcommittee subpoenaed Cadden to appear.

The Senate Health, Education, Labor and Pensions Committee, with Republican Sen. Lamar Alexander as a member, will follow with a similar hearing Thursday.

“This is the largest drug-related public health crisis in recent memory,” Rep. Edward Markey, D-Mass., said Tuesday in a statement.

Markey and Blackburn are both members of the Oversight and Investigations Subcommittee.

Blackburn said the panel is concerned “about what went wrong” and “where they (NECC) went wrong in their processes.”

But she added it is too early to say what, if any, additional authority should be given to the FDA and that Congress “should not burden or hinder” the overwhelming majority of compounders, who fill a critical need in the nation’s medical system.

Compounding, as understood for decades, meant individual pharmacists in neighborhood drug stores mixing medicines to meet the needs of individual patients as prescribed by their doctors.

But over the last two decades, many large-scale compounders like NECC have emerged — and have escaped the regulations imposed on major pharmaceutical firms.

Another question on Blackburn’s mind, spokesman Mike Reynard said, is whether the FDA “failed to use authority they already had.”

Several independent observers contend the FDA did indeed already have the authority to deal with NECC and failed to exercise it.

Meanwhile, in regard to the importance of Thursday’s hearing, Alexander said: “Americans are accustomed to going to the pharmacy confident that the medicines we buy are safe. That confidence has been shaken. At the hearing, I will be asking the questions Tennesseans themselves would ask.”

Among those questions, he said in a statement, are:

• “First, how in the world did this happen? Who is responsible for this breach of the public’s trust?”

• “Second, whose job should it be: the Food and Drug Administration’s, or that of the Massachusetts Board of Pharmacy and other state boards of pharmacy?”

• “Finally, why weren’t the federal and state regulators talking to each other about this?”

David Ball, spokesman for the International Academy of Compounding Pharmacists, said Tuesday his group believes Americans still regard most compounders as “one-medicine-per-one-prescription” professionals.

“We think the public understands NECC to be a manufacturing operation rather than a compounder,” he added.

Ball’s group is scheduled to testify at Thursday’s hearing. The spokesman declined to preview the message of that testimony.

However, the group, in a statement, endorsed one of the themes of recent legislation introduced by Markey, whose district is home to NECC.

Among other steps, Markey’s bill would make clear the FDA has authority to regulate large-scale operations like NECC. A 2007 bill sponsored by the late Sen. Edward Kennedy, D-Mass., also would have made that clear but failed to overcome political headwinds, including lobbying by the IACP.

“Drug manufacturers are not compounders, and for that reason the IACP ... supports ensuring that the FDA takes action against any business engaged in illegal drug manufacturing while still preserving the individual state’s authority and right to govern the practice of compounding (pharmacies),” the IACP says of its position now.

The group added that it also supports allowing collaboration between the FDA and pharmacies when compounding is needed to fulfill drug shortages or protect public health.