Heparin v. Avastin: hearing reveals few strides made toward safety since 2008
Watching today’s Energy and Commerce subcommittee hearing on “PDUFA: Medical Innovation, Jobs and Patients” was a little like watching a tennis match and a hockey game at the same time: It was possible to keep track of where the ball and puck were, but you had to remind yourself that the net meant two different things.
Republicans who outside the committee room have backed aggressive budget cuts for the FDA, leaned on the agency to relax everything from new drug approvals to conflict of interest rules (plus engaged a little post-game scolding over last week’s Avastin hearing.)
Meanwhile, longtime committee members and drug safety advocates Reps. Henry Waxman and John Dingell pointed to persisting gaps in the FDA’s resources and authorities that have left the U.S. drug supply vulnerable to another heparin-like crisis, and to a bill—HR 1483, the Drug Safety Enhancement Act—that would finally close many of those gaps.
“It is in no one’s interest to have a weak FDA,” Waxman said. “If Americans lose confidence in the FDA, they will lose confidence in the pharma industry as well. The FDA needs the resources to protect us for unsafe drugs, and to be sure these drugs work.”
The FDA’s representative at the hearing, Dr. Janet Woodcock, mostly stayed on message (with the exception of some flummoxed finger-pointing at the FDA field inspector’s union when asked about the agency’s difficulty inspecting enough foreign drug-making facilities.) Her message was: FDA’s job is to keep patients safe, and make sure drugs work. The agency is an important piece of the innovation pipeline, she said, not an impediment, but it also lacks some resources and authorities it needs to fully carry out the safety part of its mission.
Woodcock incisively turned back some Members’ suggestions that a dried-up development pipeline was FDA’s problem. She highlighted improving approval trends and pointed to a recent McKinsey study of phase three failures which found that 50 percent failed because the formulation worked no better than a placebo.
“It’s really hard to blame that on the FDA,” she said. Woodcock also warned against thinking safety problems are the sole province of generic drug makers.
“Heparin was not a generic drug,” Woodcock said. “This is not a generic drug problem–this is a pervasive drug quality problem.”
Concern for the FDA’s ability to protect the supply of imported drug and raw materials coming into the U.S. came from both sides of the witness table. The Pew Health Group’s Allan Coukell said in a report due out next week, his group found surprising consensus among stakeholders and likely voters for more industry-led quality improvements, legislative solutions like the ones in HR 1483, and FDA inspections. In fact, he said, generic makers and API manufacturers have said they are willing to pay more for additional inspections.
But Congress hasn’t acted, he said.
Texas Rep. Burgess said he was waiting on FDA to finish its investigation of the 2008 heparin crisis. But Coukell suggested that’s a mistake.
“Heparin illustrates a lot of weaknesses that we know about now. It was a wakeup call—FDA and others have said that. And I think we do know what we need to know.”
But, perhaps it was senior committee member John Dingell who best illustrated the short distance we’ve gone since the heparin crisis three years ago. (Sadly, PostScript had some hearing deja vu to last year, when former Deputy Commissioner Joshua Sharfstein answered many of these same questions, asking Congress for a series of critical powers it hasn’t granted yet.)
Dingell asked Woodcock for yes or no answers to a series of rapid-fire questions.
Do you have, he asked:
–the ability to control the safety of pharmaceuticals imported into the U.S.? –the authority and resources to control the safety of raw materials coming into the U.S.? –the necessary resources to ensure overseas drug manufacturers are properly observing Good Manufacturing Practices (GMPs)? –the necessary resources to ensure that raw materials suppliers also engage in GMP abroad? –the resources to inspect foreign facilities with the same frequency as domestic ones? –the ability to share findings on inspections or quality problems with trusted regulatory partners? –the authority to require a manufacturer to notify you if they suspect a drug has been counterfeited, adulterated, or misbranded? –the power to refuse imports you suspect of being counterfeit or adulterated at the border? –the authority to recall drugs you believe to be substandard or unsafe? –the authority to recall imports and raw materials?
To each of these, FDA’s Woodcock gave an immediate, square answer: No.
How often can you get by to see foreign drug manufacturing facilities? Dingell asked.
Every nine years or so, Woodcock said.
And dog food making facilities? he said.
About every year, she said.
Do you need these additional authorities? Dingell asked.
Absolutely, Woodcock said.
Would HR 1483 have afforded you the authorities you need to deal with the heparin problem?
Yes, she said.
–Kate Petersen, PostScript blogger