In a sort of Capitol call-and-response, the powerful Senate Judiciary Committee pledged to take up legislation to combat counterfeit medicines as Sen. Michael Bennet pledged to expand his own bill, the Drug Safety and Accountability Act, and seek bipartisan support for it.

“Having a safe drug supply is not a Democratic or Republican issue. It’s an issue of national security and consumer safety,” Sen. Bennet said today to the After Heparin conference sponsored by the Pew Health Group.

What about drug companies that hire overseas suppliers in plants they’ve never inspected or even seen? Pew’s Allan Coukell asked (see yesterday’s post). Sen. Bennet’s bill would look to address that, he said. “The notion you could buy from suppliers without knowing who they are is shocking to people,” the Senator said, “and should be shocking to people.”

Shocking didn’t stop there. It seems we are indeed in the “Upton Sinclair period of the world,” as the US Pharmacopeia’s Roger Williams described. In California, 7,000 hospital patients were exposed to heparin after the recalls began three years ago, said panelist Virginia Herold, head of the California Board of Pharmacy. Only 18 percent of California hospitals had pulled the recalled blood thinner three months after the first recall. Telling stories of Chaucerian color—discovering counterfeits accidentally through medication errors, different-colored pills in the same bottle—Herold made a compelling argument for the first-in-nation e-pedigree law California is working to implement now, the national need for one, and better enforcement of existing monitoring systems.

Herold’s own ‘after heparin’ story also illustrated the potential dangers the current industry-led drug recall poses to the public. Both Sen. Bennet’s  bill and several others introduced last year in the House would give the FDA mandatory recall authority, which the agency has requested publicly in the past.

If yesterday’s convening generated deep agreement that the safety and quality systems that guard the US drug supply are in need of a major revamp, today’s sessions brought a different consensus: the problem of falsified and counterfeit drugs in the legitimate US drug supply is big, and has real if uncountable effects on clinical care.

It’s the economy, stupid When it comes to why the faked and adulterated meds problem is so widespread, it seems the old maxim is true: Counterfeiters can thrive in a multi-billion dollar global market in which many cannot afford the retail price of their medicine, in which a cheaply-made talcum tab can be sold for $40 a pill, in which enforcement is irregular and lax and penalties relatively modest. And drug shortages and market interruptions are particularly ripe opportunities for such criminals to infiltrate the legitimate supply chain.

Accounting for why people seek medicines outside the traditional brick-and-mortar pharmacy model is fundamental to figuring out how to curtail counterfeiting and breaches in the legitimate drug supply, said Roger Bate of the American Enterprise Institute. “If we don’t address that people are buying from overseas, we can’t make it safer.”

Bate and Coukell said defining terms is important. Counterfeit, defined as a violation of patent and private rights, is not the same counterfeit at the center of these safety talks: any substandard, adulterated drug that violates or compromises the public health. In parts of the developing world, Coukell said, there’s concern that safety can be used as a stalking horse for intellectual property rights and may get in the way of access to life-saving medicines.

Four post solution Proposed solutions for keeping counterfeits and substandard drugs out of US medicine cabinets clustered around four main ideas:

Bring transparency and accountability in the supply chain, chiefly by a uniform electronic tracking system that would ID the drug and provide an unforgeable trail from supplier to pharmacy shelf (see here for more).

Help public make good decisions. Inasmuch as we can know about the quality and safety of distributor sources, educating the public about where to get their medicines—or where to avoid getting them—is key. As Bate and others pointed out, this is made challenging by widespread use of online pharmacies and drug sellers despite U.S. re-importation laws. Panelists agreed there’s big quality disparity between the worst and best overseas factory, and the worst and best distributors, but not on how to communicate that to a public driven primarily by price.

Coordination is key. From e-pedigree proposals, to counterfeit enforcement operations, to communicating recalls, coordination is essential, the experts said.

More robust enforcement and stiffer civil and criminal penalties are needed to find bad actors and then hold them accountable.

Urgent Care Many panelists expressed a common urgency that we find a way to stanch the flow of bad and substandard drugs into the U.S, and there was wide consensus that a national and uniform prescription drug tracking system is needed. But the wherefore and when’s—including the need for a federal statute, the road to implementation, and the cost outlay—are still questions.

From a systems perspective, pedigree is paramount, but former Florida drug inspector Cesar Arias said that it is also critical at a case-by-case level for investigations and needs to be implemented nationwide. “Without it, we have nothing.”

Those representing drug stores and small distributors said a level playing field was crucial and raised concerns about implementation cost and time frames of electronic tracking laws. But the when-not-if ingredients for another heparin crisis are all here, and require quicker action, many said.

“It’s really time now for some significant action, on pedigrees, and on other steps,” said Carmen Catizone, Executive Director of the National Association of the Boards of Pharmacy “They were needed yesterday, and they’re needed today.” Catizone compared it to the barcode that prevents stolen or illegitimate retail items from being returned to another store. “We need to give the same value we put on apparels and CD on the drugs we take to save our lives.”

So what’s it going to take? National Coalition of Pharmaceutical Distributors Karen Moody said to get track-and-trace adopted, federal law is needed: “If there isn’t a mandate, it ain’t gonna happen.” Rx-360’s Martin VanTrieste agreed that federal law is needed to get an e-pedigree system going: “We need a 800-pound gorilla in the room, and that’s the federal government.”

But until that happens, After Heparin showed there is much that can and must be done. “We should not make the perfect the enemy of the good,” Arias said. “We need to use the tools we have to do the job and protect the public.”

Find archived webcasts and more about After Heparin at Pew Prescription Project and Community Catalyst.

Want to read something shorter about drug safety? Try us at Twitter: @SafeRxWatch.

–Kate Petersen, PostScript blogger