Meningitis outbreak offers lawmakers a chance for rare bipartisanship

Fungal meningitis doesn’t care whether its victims are Democrats or Republicans.
That’s why Tennessee’s congressional delegation should join together, party with party, and sign on to a proposed new law that would give the U.S. Food and Drug Administration clear guidelines to enforce safety at compounding pharmacies.
U.S. Rep. Edward Markey, a Democrat, represents the Framingham, Mass., community where the meningitis culprit, New England Compounding Center, is located. His proposed bill recognizes a giant hole in regulation of pharmacies that compound their own drugs: No one has taken ownership of enforcing the laws they ignored.
The truth is the FDA had the tools all along to stop this. But it wasn’t vigilant, dumping responsibility on state pharmacy boards. As we know by now, they didn’t get the job done.
Drug compounding has been used traditionally by doctors and pharmacists to make medication that wasn’t commercially available for a patient. But some companies, like the one in question, twisted that to set up widespread manufacturing of drugs to compete with more expensive ones already on the market. In this case, inspectors found massive amounts of what looked like mold in the plant.

The tainted steroid injections have made 78 Tennesseans sick, and 12 of them have died. Nationwide, 387 people have contracted fungal meningitis and 29 have died.
Attorney Peter Barton Hutt, chief counsel at the FDA in the 1970s, told Tennessean reporter Josh Brown that a 1938 law gave the FDA the power to stop this entire fiasco from happening. That law said companies cannot stockpile drugs, and if there is an approved drug already on the market, they cannot compound a competing drug. This firm apparently violated both of those rules. The FDA sent them a letter in 2006 warning them they were not supposed to be manufacturing commercially available drugs, and that they were illegally making medication without a prescription.
But the FDA, citing a lack of resources and two court cases, chose to leave it up to state pharmacy boards to do the enforcing. And that has not happened.

No commitments

Markey’s bill would make enforcement of the law much easier. It would require pharmacies that sell drugs across state lines to register with the FDA and comply with minimum safety standards. It would also require patients to be warned if they are given a drug not approved by the FDA.
When he announced his plans, two Tennessee lawmakers weighed in.
U.S. Rep. Marsha Blackburn, R-Brentwood, said the FDA “plays a critical role in ensuring the safety of our nation’s pharmaceuticals.”
Sen. Lamar Alexander was similarly cautious: We need to “do our best to make sure this never happens again,” he said.
Neither said whether they will support Markey’s bill; nor has U.S. Rep. Jim Cooper, D-Nashville, or any other from Tennessee’s delegation.
But they need to. Patients should have confidence when they go to a doctor for relief from back pain, not fear. And that confidence can only come if the agency responsible for enforcement is written in stone.
It won’t heal the ill people being treated or bring back those who died. But clear enforcement rules could stop this from ever happening again.

Gail Kerr’s column runs on Sundays, Mondays and Wednesdays. She can be reached at 615-259-8085 or gkerr@tennessean.com.