The news that Josh Sharfstein is leaving the FDA, where he has been deputy commish for slightly less than two years, came as something of a surprise to many (back story). A Harvard-trained physician and former Congressional investigator with a penchant for criticizing pharma, Sharfstein arrived along with Margaret Hamburg, the FDA commish, and the pair was seen by pharma critics as white knights who could help restore some luster to a tarnished agency, while industry worried they might create havoc. Sharfstein is expected to become the secretary of health and mental hygiene in Maryland, and so we asked Ira Loss of Washington Analysis, a long-time observer of the intersection between pharma, Wall Street and Capitol Hill, about this high-profile change…

Pharmalot: Were you surprised Sharfstein made this kind of move?
Loss: I think he’s got a nice job offer. He’s a public health official. That’s his strength. That’s what he did before he came to the FDA (he was Baltimore health commissioner). And it seems like a logical fit that the Maryland governor would reach out for a known quantity when he wants to make a change in public health. I don’t know it’s particularly surprising he would go back to public health after two years. But it’s also fair to say Sharfstein and Hamburg brought a public health mindset to the FDA, which was sadly lacking in the previous administration. You could see that in their approach to food safety and swine flu. They framed public health in a way that helped the public understand.

Pharmalot: Where do you think he had the most impact?
Loss: His biggest impact was with medical devices. He was the main force behind the investigation into the Menaflex knee device (see this) that led to a reevaluation of the 510k approval process, which is still ongoing and which will ultimately result in some changes to the requirements for some 510k applications. It’s probably a long overdue and badly needed updating. That industry tends to complain a lot about change, but I think most objective observers would say it was time to take a look at this. And the FDA held a public hearing on the subject and the only witnesses that showed up were from industry and they spent the whole time complaining. But many complaints they lodged were addressed in proposed changes. From that standpoint, he had a big impact.

Pharmalot: What about with prescription meds?
Loss: Well, yes, he was also involved in the decision on Avandia (look here). He had a reputation for being anti-industry. He was an activist in medical school about freebies given to students. So it was assumed he would be an awful person to the drug industry. Meanwhile, the Europeans kicked Avandia off the market. And he could’ve advocated for taking it off, but instead they used the REMS program (and left Avandia on the market).

Pharmalot: What impact do you think his departure will have?
Loss: In all honestly, I’m a bit concerned about his departure’s impact on what the FDA will have to endure with the new Congress with Darrell Issa (a Republican who now heads the House Committee on Oversight & Government Reform) wanting hearings to look at FDA activities in who knows what areas. He hasn’t been too specific. He says he’ll issue subpoenas.

Pharmalot: Why does that worry you?
Loss: Sharfstein was exceptional in the way he performed in front of Congress. He came in with a confident attitude and wasn’t easily cowed. And that was not the case with (former FDA commish Andy) von Eschenbach and some characters in the last administration. They basically acted like they didn’t know what anybody was talking about. A situation where Congresss is beating up the agency is bad for industry. It slows down work product and makes people at the agency unsure if their back is covered. It’s really important for the person that responds to subpoenas to be tough and not act like he didn’t know what he’s doing.

For the most part, people in Congress really don’t have a lot of knowledge about subjects into which they’re holding hearings, particularly the vaccine area. I saw him when he showed up for the flu hearing. He commanded the subject in such a confident way that he had senators eating out of his hand by the time he left. He knew what he was talking about. It was a good introduction for Congress to see what this guy was about. That he not just another Joe because he knew somebody politicaly. There are not a lot of people with that kind of knowledge.

Pharmalot: What might this mean for the pharmaceutical industry?
Loss: In the short term, there’s a minus because a capable person won’t be there anymore. But it’s a job that doesn’t require Congressional approval, so you don’t have that hurdle to go over, which is the reason, I think, he was made No. 2 in the first place. The administration felt he would encounter delay (getting approved for the commissioner’s job) if not outright rejected, and that would not be what they wanted for an agency. I think he turned out to be, from the pharmaceutical industry standpoint, a pretty good deal. He didn’t really get in their hair the way they feared he might. Of course, they might have tales to the contrary, but I’m not aware of them.

Pharmalot: Yet, it’s only since and he Hamburg arrived that more warning letters were issued and they made noise about holding individual executives accountable for illegal activities.
Loss: That was mostly noise, other than the lawyer from Glaxo who got indicted. I don’t know there was a long list of people who got in the crosshairs. The other thing is that greater enforcement was a mirror image of what the Clinton administration did. Look at the early days of Bill Clinton, when David Kessler was converted from Bush One commissioner to Clinton commissioner and he became a major enforcement guy. It was during that administration that the approach was to go after a couple of big fish in hopes others would fall in line.

You may remember one of the first actions they took was for marketing an orange juice called Fresh, but it wasn’t fresh, it was from concentrate. They brought action and there was corrective advertising and a lableling change. There was also Bristol Myers, which was one of the leaders in oncology and showed up at an ASCO meeting w/brochures on their portfolio that mirrored the compendia recommendations on how to use the drugs. But it had nothing do to with the labeling. The FDA was all over them for improper marketing. The emphasis was to try to get industry attention and I think it’s ultimately going to happen here, too. Everybody has to polish the handles a little better and behave themselves.