In his keynote address to the “After Heparin” convening today, FDA Principal Deputy Commissioner John Taylor said the agency has not made enough progress in transforming its oversight system, but that bills before the last Congress—the Bennet and Dingell bills–could help accelerate that process.
He also laid out a global strategy plan to revamp its monitoring system that would rely more on third-party inspections, improved risk-based intelligence, data-sharing and cooperation with partners in the public and private sectors.
Taylor brought big numbers to illustrate the big gap between the domestic nature of FDA’s founding mission and the new global realities. There are 300,000+ FDA-regulated products coming into the U.S. from 150 countries. By 2008, Taylor said, the U.S. import imbalance on pharma products had increased 10-fold, to $18 billion.
The impressive range of stakeholders around the table today – from chemical manufacturers to consumers representing the patient who takes her medicine – covered a lot of ground and came to some important consensuses around needed policy reforms to close the gaps. Here are some major themes:
Info-sharing/collaboration One common refrain from Taylor’s keynote to the closing remarks was the need to share information strategically on safety and monitoring systems. Martin VanTrieste, head of Rx-360, a non-profit industry audit-sharing organization, promoted the efficiencies his group has gained in sharing audit info and planning group audits, which offer the potential for more in-depth visits and cuts down on redundancy.
Falsifying drugs is a perfect crime, said Guy Villax, board member of the European Fine Chemicals group and CEO of Hovione, and he proposes to tackle it with info-sharing databases like the one the European Medicines Agency has developed.
Inspectorama Inspections remain an important piece of the overall quality picture, though everyone agreed there aren’t enough resources to inspect anywhere close to all the sites that make raw materials and substances that go into U.S. drugs. The 2010 GAO update and last night’s 60 Minutes (and the PostScript archives) all have those numbers.
FDA’s Deb Autor said that gaining parity between domestic and foreign inspections are just not feasible, and in some cases, the every two years required for domestic sites would be excessive, even wasteful. But Marcia Hams of Community Catalyst reminded the group that it’s partly that very level of inspection that allowed regulators to find and monitor the flagrant quality problems at Johnson and Johnson’s three domestic factories—and to eventually take them over.
Who’s gonna pay for this? There was, predictably, less consensus about how to pay for inspections. Though all agree that cost-savings is the major driver in the shift of supply and manufacture to emerging markets, Prabir Basu of the National Institute of Pharmaceutical Technology and Education, said that cost savings is directly linked to the low- or un-regulated climates of those markets, and can’t be accounted for by labor costs alone. But it’s unclear that the greater risk that comes with industry savings is being matched with a willingness to spend on safety and quality systems.
One solution discussed was a user fee that would go toward inspections; right now user fees go to pay for approval. But Mylan President Heather Bresch said that a user-fee system should be holistic – that is, it should support bringing safe, quality products to market and then ensure their safety once they’re on the shelves.
Cheating to the test The culprits responsible for the adulterated heparin linked to the American death developed a molecule that fooled up more than a dozen different country’s and companies’ tests, including the US Pharmacopeia, which now has an updated heparin assay. USP’s CEO Roger Williams said that a thoughtful updated test is a critical factor in assuring safety and quality, and called for legislative support for such standards.
But physical audits are absolutely key, said Philippe Andre, a China-based auditor whose photos bore that out. Andre and Brant Zell, past chair of the Bulk Pharmaceuticals Task Force, both underscored that when it comes to working with overseas suppliers, knowing what you’re getting ahead of time is critical. Andre said he’s surprised by how many companies contract with suppliers in China without ever visiting the plant. And Zell pointed out the importance of companies doing proactive physical audits. “If you just test, you don’t get all the answers,” he said. “Quality’s built-in, and if you visit, you get an idea about how things are being done.”
National Security Rx Drug safety is, at its core, a national security issue. An industry in which bad actors are economically motivated and able to infiltrate the legitimate supply chain with a relatively low risk of penalty is ripe for exploitation, and in this way, heparin is a shadow of the bioterrorism threats that captivated the nation a decade ago and caution for the bigger crises inevitable if the system goes unfixed. Attendee Laurie Garrett from Council on Foreign Relations pointed out that one of the lesser-hyped documents in the Wikileaks case was a State Department memo listing of overseas sites of national security interest to the U.S.: more than 30 percent were drug, vaccine and biological manufacturing sites.
Nearly all the parties around the table agreed that the safety gaps in the pharma supply pose a great and growing threat to public health, and that incremental scale-ups won’t solve the sort or scope of risks that the new globalized drug supply chain pose.
This has got to be a paradigm shift. And we fail to make it at the patient’s peril.
“We just need to figure this out, we just need to step it up,” said AARP’s Ahaviah Glaser. “As a consumer rep, I still look to the FDA, but it’s got to be group accountability.”
“If we can’t trust where our drugs are coming from, that’s so fundamental,” said Cleveland Clinic cardiologist Harry Lever. “If my patient isn’t doing well, the first thing I think about now is: maybe it’s a drug.”
Allan Coukell of the Pew Health Group, which hosted the convening, said he was encouraged by the caliber of the discussion: Significant common ground was gained, wide agreement forged on some policy reform proposals, and all with very little finger-pointing.
Hams asked FDA’s Taylor how he saw the role of the consumer: How do we engage the people taking the medicines around safety, and communicate the need to be both vigilant and compliant?
To a degree it’s good, Taylor said, when consumers take the FDA for granted. When their aspirin is safe, and works, then the agency is behind-the-scenes and doing its job. But he agreed of the need to figure out how to engage the public: “We’re going have to explain why we think these changes are necessary…in a way that actually affords consumers an extra level of confidence that the world is changing,” and that the rules must change to meet it.
“We can’t take for granted that folks know that [this] world is changing.”
Tune in tomorrow for Day Two, and follow @SafeRxWatch on Twitter for short, live tweets from tomorrow’s sessions.
–Kate Petersen, PostScript blogger