Hamburg to PhRMA: If you don't have quality, the rest doesn't matter

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

A strong regulatory agency and the patient confidence it inspires are essential for both patients and the industry as a whole, Sanofi ($SNY) CEO Chris Viehbacher said Thursday. And while the FDA has made recent strides in restoring the patient trust the agency depends on, Commissioner Margaret Hamburg says it still has some work to do.

Speaking at the PhRMA's annual conference in Washington, DC, Hamburg highlighted recent reasons for concern that quality standards are not being adhered to--as well as the agency's renewed focus on enforcing those standards.

"We are … trying to really reshape some of how we address the quality issue, to try to incentivize better practice and more accountability around quality," she said. " … And I think this is the time when we need to be recommitting to it."

Part of that, she said, has involved creating a new Office of Pharmaceutical Quality and putting it on par organizationally with other critical offices, like those for new drugs and safety. Another part has been recognizing the need to become a global agency--one that not only has offices and inspectors on the ground around the world, but also has working relationships with counterpart regulators, harmonized regulatory approaches with those counterparts, and a new kind of partnership with the industry.

"We didn't mean that we were going be the regulator for the world," Hamburg said. "What we meant was to do our job--to protect the health and safety of American consumers--we could not simply constrain ourselves to the products that were within our borders."

Major quality issues have surfaced both at home and abroad as of late. In 2012, an outbreak of fungal meningitis traced to a New England compounding pharmacy caused 64 deaths and sickened more than 750 others; the FDA has since worked with Congress to pass the Drug Quality and Security act, which broadened and defined the agency's authority over drug compounders.

The agency has also identified a host of quality issues in emerging markets, particularly India. Problems there including data-tampering and unsanitary conditions have landed more than a few Indian plants on the FDA's import ban list, prompting Hamburg this year to make her first trip to meet with regulators there.

But even with these efforts, there's a fair bit of room for improvement. For one, she said, high-risk products like sterile injectables need to be produced with proper attention for sterile procedures. Advances in science and technology can make a difference, too: Pharma can use quality by design, continuous manufacturing and other approaches to help improve both quality and efficiency in the production process, rooting out preventable problems that create shortages and compromise patient trust.

"It's just so fundamentally important," she said. "If you don't have quality, all the rest of it really doesn't matter."

Special Report: The 25 most influential people in biopharma today - 2012 - Dr. Margaret Hamburg