Law under the Microscope

Crawford Still Under Fire

As a commenter to a past post noted, a dynamic physician with business savvy would be crucified at the FDA.  Alas, that commenter is likely correct. There are always people who will try to bring down someone who could bring necessary changes and enliven an institution.

But it might be that the current administration will not be able to rely on having its current non-dynamic physician appointed as the FDA Commissioner.  Some  Senators on the Health, Education, Labor and Pensions Committee, which will be considering the issue on Thursday, have made it very clear that they will be putting a "hold" on the nomination of Dr. Lester Crawford as the permanent FDA Commissioner (he has been the Acting Commissioner for 18 months or so now).

FDA, WHO Create More Web Sites to Help Decipher Drug and Vaccine Safety Information

More than one political pundit has deemed our current time as the Information Age. We're constantly inundated with data - some mundane, some crucial, much of it not-quite-so-accurate.

In the medical arena, omitting information or disseminating partial or inaccurate info can be annoying at best, fatal at worst.  In an effort to try to keep the public better informed about drug safety issues, the FDA is preparing to launch a new Drug Watch webpage. Likewise, to combat the myriad of websites that contain false or misleading information about vaccine safety, the World Health Organization (WHO) has created a list of 23 websites that it considers "reliable."

FDA Still in Need of Leadership

The FDA has been without a permanent commissioner for about a year. It was exciting when, just a couple months ago, it looked like Dr. Lester Crawford would move up from being the Acting Commissioner to being the permanent Commissioner. Alas, his confirmation was blocked by two Senators and the FDA is still in limbo.

The reason for the blockage is rather substantial - Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) are concerned about the FDA's dragging its feet in making a decision about approval of OTC Plan B contraceptive. The contraceptive is strongly opposed by conservatives, but all scientific evidence states that it is safe and effective, so its prohibition from being on retail shelves appears to be entirely political.  As the FDA is supposed to be making decisions based on science rather than political winds, this is rather alarming.

NIH Still in Ethical Quandary

I have to imagine that there are some days where the director of NIH, Dr. Elias Zerhouni, just wants to run down the hallway with his fingers in his ears yelling "LA LA LA LA LA!"  In the last year, one of the stickiest issues the NIH has faced and that has gained huge public attention is the dilemma regarding outside compensation to NIH scientists by corporations.

To sum up the issue - until last year, NIH scientists were able to receive a certain amount of compensation  from outside corporations, so long as they disclosed that work. Then it came out that maybe two dozen of the thousands of NIH employees (researchers and non-researchers) had received rather hefty sums of money and it wasn't clear in each case whether those amounts were disclosed.  Following Congressional hearings on the issue, Dr. Zerhouni placed a moratorium on any scientists receiving outside compensation for their work.  In February, a new interim final rule was put in place that allows non-researchers to have up to $15,000 in stock holdings of pharmaceutical companies, and no NIH employee may perform any compensated speaking, editing or writing for a regulated entity or any uncompensated outside employment. In addition, no senior employee may receive any gift or award because of their NIH position that is more than $200 in value.

Oh, who knew how many problems this would bring to NIH ...

FDA and SEC to Work Together to Monitor Biotech Companies

Like the superheroes in the Hall of Justice pledging to stand by one another, the SEC and FDA have finally come together and agreed to cooperate better in investigating claims made by biotech/pharma companies about their dealings with regulators.  Ever since the incident in 2002 regarding Sam Waksal's sale of shares of Imclone right before it was announced that the FDA would likely not approve its drug (which also lead to the Martha Stewart trial for obstruction of justice).

This is my favorite quote from the article the talks about the recent meeting in which the SEC and FDA announced their new alliance:

Some executives at the session said they weren't pleased by the extra work taken on by the FDA.

''It amazes me that people at the FDA have time to read securities filings," said one executive, who asked not to be named.

At least he had the good sense to ask not to be named.

NIH Researchers Can Receive Consulting Fees, Cannot Hold Stock in Biomedical Companies

You may recall that the NIH had come under fire when it was revealed, after inquiry by former Rep. Greenwood, that some NIH researchers had received rather substantial consulting fees from biomedical companies that they had not disclosed. The NIH had reacted then by issuing a moratorium on all employees from receiving any funds at all from external sources for research until it issued it's final rule on financial arrangements between NIH researchers and biotechnology companies.

The NIH has finally issued its rule in an internal memo, and it's not quite as harsh as first proposed, but still has tighter restrictions than had been in place a year ago.  The new rule is that temporary researchers can retain their stock holdings in such companies, and permanent researchers must divest such holdings by October, 2005. There was no prohibition placed on receiving money or other compensation  from biotechnology companies.

Grassley Issues Proposal for Independent Drug Safety Office

As expected, Sen. Charles Grassley (R-Iowa) is making rumblings about his soon-to-come bill to create an independent drug safety review office that will have increased capabilities for issuing warnings to drug manufacturers.  Several critics, including Sen. Grassley, have been going after the FDA for its internal structure that supposedly intimidates certain FDA scientists from waving red flags about approved drugs to their superiors, because those superiors have already approved the drug and the scientists fear retaliation.

I am really looking forward to seeing what his proposal is, for several reasons ...

NIH Clears Most Researchers in Ethics Investigations

On Feb. 3, NIH Director Elias Zerhouni issued a moratorium on researchers receiving compensation for "extracurricular" activites, and forbade NIH employees from holding stock in biotech companies. This was in response to a brewing scandal about certain researchers who allegedly entered into contracts with pharma companies without notifying the NIH of their deals.

FDA to Implement New Oversight Board

It looks like the HHS and FDA is doing what it can right now to appease its critics within and outisde the government. This week, HHS Secretary Mike Leavitt announced that Lester Crawford, the Acting Commissioner, was being nominated as permanent Commissioner of the FDA. That is a great step, as it was necessary to get someone into the position (and, curiously, there were no other names bandied about as competition - makes me wonder why the administration didn't act on it sooner).

The FDA also announced, before 3 days of Congressional hearings, that it was going to implement a new independent Drug Safety Oversight Board. This board is something of a response to the recent scandals about drugs such as the Cox-2 inhibitors, Vioxx and Celebrex.

NIH Impose Strict Rule on Employees Regarding Financial Conflicts

The NIH has issued its new rule regarding its employees and potential financial conflicts, and it's a lot stricter than most had thought it would be. Although prior rules were somewhat difficult to sort out, the new one leaves little room for fudging.