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FDA struggles to be more accountable

Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, told packed house at Harvard Medical School Wednesday night that the agency has a way to go to provide accountability for its decisions.

Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, told packed house at Harvard Medical School Wednesday night that the agency has a way to go to provide accountability for its decisions.

“A lot of the accountability right now, frankly, comes from me or [FDA head Dr. Margaret] Hamburg,” Sharfstein said. “If someone says something that doesn’t make sense, we’ll push them on it and there will be a whole of hand-wringing, but I wouldn’t tell you that we’re where we want to be.”

Sharfstein was part of a panel at the medical school’s World Health Forum addressing “New Regulatory Initiatives.” The discussion was dominated by the lack of accountability at the federal watchdog agency, with moderator David Meeker, COO at Genzyme Corp. (NSDQ:GENZ), fielding the first question: What’s the biggest barrier to advancing regulatory science at the FDA?

American Enterprise Institute resident fellow Scott Gottlieb, a former FDA deputy commish himself, said the FDA has no “internal peer review mechanism.”

“Rank-and-file people in the agency aren’t necessarily held accountable for the quality of their scientific work,” Gottlieb said. “I know that sounds heretical in a scientific organization.”

In academia or similar scientifically driven institutions, the goals may be professional recognition and advancement within that institution. In private industry, the goal is to make more money; individuals within business don’t get to set their own standards. In a regulatory body, the goals for employees are compliance with legal or bureaucratic requirements.

“If you look at how [the Center for Drug Evaluation and Research] operates,” Gottlieb said, “people are promoted, their salaries are increased, based on things that have to do with how they process work, how quickly they can process applications and move through the cycles.”

Sharfstein said the FDA describes the predicament of regulatory science as akin to a rower with one strong arm and one weak, flabby arm. The strong arm is the investment going into biomedical research; the other arm is regulatory science, “which is the tool that we have to evaluate whether these products are safe and effective,” he said.

“One of the things that can address the question of whether there is adequate scientific work being done by the agency is whether people can really see the work of the agency and if in fact we’re making decisions and explaining them and it’s defensible,” Sharfstein said. “If we’re just making decisions and never having to explain them, then a company can be upset, but there’s no self-correcting mechanism.”

Sharfstein asked if anyone had heard of the FDA’s “organization performance management” program, FDA-TRACK, but only Meeker spoke up. He’d come across it in his research for the panel.

The program is only about seven weeks old, but its status as unknown — especially among a crowd likely to be most affected by it — may have prompted Meeker’s next question.

“Is there enough pressure on the FDA’s accountability system for it to work?” he asked.

“The only way to structurally bring more accountability at the scientific review level, is to subject it to more outside scrutiny,” Gottlieb said, adding that the FDA does that through its advisory committee process. But by the time a drug or device has reached that stage, he said, a lot of time has already elapsed. That means potential patients have gone untreated and investments may have dried up.

Major changes to the review process of drugs and devices can’t be made without legislative changes, Gottlieb noted. In order to be compliant with the Federal Advisory Committees Act, the agency is barred from bringing in more than two outside experts during a review without opening up the process to the public, a step that could compromise intellectual property.

Some members of Congress are paying close attention to the FDA’s bureaucratic issues. A bipartisan group of 12 representatives sent a letter to Hamburg Oct. 12, asking for more transparency from the watchdog agency as it makes changes to its 510(k) medical device clearance program.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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