Reg•Watch is retroactively declaring March 22, 2007 Scrutinize the FDA Day (see below). Here's one more bit of news before this soon-to-be widely celebrated holiday comes to a close.

This morning, the House Energy and Commerce Committee subcommittee on Oversight and Investigations held its second hearing on the FDA drug approval process. Panel Democrats grilled FDA commissioner Andrew von Eschenbach on how the agency has become powerless in regulating drugs, especially after they reach the market. Committee Chairman John Dingell (D-MI) repeatedly criticized the culture at FDA as a contributing factor. OMB Watch has reported on the increasing need for reform in the agency's drug approval process.

The hearing also featured testimony from Marcia Crosse — not the desperate housewife, but the Government Accountability Office director for health care. Crosse's testimony pointed out FDA has begun initiatives to correct some of the problems detailed in a 2006 GAO report, but it is too soon to tell how effective those reforms will be.

Also of note, at least one lawmaker, Rep. Jan Schakowsky (D-IL) mentioned FDA's new guidance on advisory members which Reg•Watch mentioned earlier today.



Posted by Matt Madia, 05:19:03 PM



FDA Risk Assessment Favorable to Food from Clones

The New Standard has published an article outlining how the FDA has "cherry-picked" data in formulating a favorable risk assessment for food products from cloned animals.

Read the article here.
Read the Center for Food Safety report on the issue here.
Read the FDA draft risk assessment here.



Posted by Matt Madia, 04:28:32 PM



Breaking down FDA's New Conflict-of-Interest Proposal

In today's New York Times, there appears a story by reporter Gardiner Harris about FDA's new guidance intending to reduce conflicts of interest on agency advisory boards. (Note: The story refers to the proposal as "rules" but it is actually "draft guidance" which, unlike rules/regulations, does not carry the force of law.)

The guidance is a response to an increasing problem at FDA: Scientists determining the public safety of drugs and medical devices often have financial ties to the products or industry on which they are commenting. There are pros and cons to the draft guidance.

The good:

• Most advisors having obvious financial conflicts of interest of more than $50,000 will not be able to serve on committees.
• Most advisors with less significant conflicts of interest will be able to serve but not vote.
• The guidance addresses not just current financial conflicts of interest, but those that have occurred in the past year.

The bad:

• The guidance is loaded with loopholes, including reserving the right of the FDA commissioner to grant waivers.
• The guidance only addresses financial conflicts of interest, not personal or professional. (This is politics! Relationships and egos are important.)
• This is guidance, not a regulation. Therefore, it "does not operate to bind FDA or the public."

The ugly:

• An advisor with a significant financial conflict of interest may still be able to serve (but not vote) if "the need for the individual's services outweigh the potential for a conflict of interest." Doesn't a big pile of cash undermine the objectivity of an "expert?" Shouldn't pharmaceutical expertise funded by a pharmaceutical company be considered ill-gotten gains?

Stay tuned to Reg•Watch for more on this.

Posted by Matt Madia, 12:56:57 PM

Tuesday, March 20, 2007

The Consumer Product Safety Commission, an independent federal agency, has launched an excellent campaign to inform consumers of product recalls. The "Drive to 1 million" aims to subscribe one million Americans to CPSC's email notifications. The emails alert subscribers to recalls of dangerous or potentially dangerous products. Sign up for free at www.cpsc.gov.



Posted by Matt Madia, 02:17:35 PM

Thursday, March 15, 2007

OMB Watch Releases Report on Bush Changes to Regulatory Process

Today, OMB Watch released a full report titled A Failure to Govern: Bush's Attack on the Regulatory Process (download it here). This report outlines President Bush's recent amendments to Executive Order 12866 — Regulatory Planning and Review. The report details the potential impacts the amendments will have on federal agencies and the American public, as well as what the changes mean to democracy at large.

A Failure to Govern: Bush's Attack on the Regulatory Process






Please Protect the Food Supply ... You Know - If You Feel Like It

On Monday, the U.S. Food and Drug Administration (FDA) issued to the produce industry guidance on reducing the risk of contamination in fresh-cut fruits and vegetables. The "guidance" (regulatory lingo for "suggestion") urges the industry to develop food safety plans. The guidance is completely voluntary.

FDA's nonchalance is odd considering recent events. Highly publicized food-borne illness outbreaks — such as the E. Coli tainted spinach of 2006 and the current case of salmonella in peanut butter — have raised concern over the safety of our nation's food supply. One would think America's leading food monitor would begin to do its job with more, not less vigor.

See this Associated Press article for more.



Posted by Matt Madia, 10:32:52 AM

Tuesday, March 13, 2007

FDA Commissioner Opposes Commonsense Tobacco Bill

FDA commissioner Dr. Andrew von Eschenbach is opposed to bipartisan legislation that would allow FDA to regulate tobacco products. Sensible bills in both the House and the Senate would dramatically improve public health as it relates to tobacco products. The bill would do so by placing the tobacco industry — which currently goes unregulated — under the purview of FDA.

In a Mar. 6 interview with the Associated Press, von Eschenbach manipulates the facts in his opposition to the bill. His specious arguments are a poorly veiled attempt to side with the tobacco industry. He also claimed tobacco products are too complex for the FDA to handle. How can an FDA commissioner hold such little regard for his own agency?

One of the bills sponsors, Rep. Henry Waxman (D-CA), wrote a letter to von Eschenbach asking him to correct his various misstatements.

Your statements suggest a serious misunderstanding of the bill and appear to ignore overwhelming evidence that such regulation is necessary to address the continuing epidemic of tobacco-related death and disease.

Waxman then discredits von Eschenbach's argument point by point. Waxman's letter is a pleasure to read (as his Bush administration proddings usually are). Check this one out here.



Posted by Matt Madia, 04:01:45 PM

Wednesday, March 07, 2007

Latest Watcher

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Bush Continues Anti-Regulatory Efforts with Industry Nominee to CPSC

Scientific Consultant Sparks Controversy over Conflicts of Interest

In Congress, No Shortage of Fuel Economy Proposals

Friday, March 02, 2007

Bush Nominates Manufacturing Ally to CPSC

Thursday, President Bush nominated Michael Baroody to be a commissioner on the Consumer Product Safety Commission (CPSC). Baroody is the current executive vice president of the National Association of Manufacturers, a trade group whose mission includes "shaping a legislative and regulatory environment" on behalf of manufacturers.

Baroody's ability to shape America's regulatory environment will take on new meaning if he becomes a CPSC commissioner. The CPSC is the independent agency charged with protecting the public from dangerous products. The commissioners (of which there are only three) must be able to work with manufacturers to assess product safety, but also exert authority when industry cooperation does not go far enough in protecting the public.

If you think a commissioner with such obvious strong ties to the industry he must regulate is a bad idea, you are not alone. Public interest groups are already sounding the alarms, and Sen. Barbara Boxer (D-CA) says she will give the nomination "thorough scrutiny," according to the LA Times.

As Reg•Watch has blogged in the past, the CPSC has been short a commissioner since July, and its voting quorum recently expired. I find it depressing to have to contemplate which is worse: a commissioner like Michael Baroody, or no commissioner at all.



Posted by Matt Madia, 10:39:47 AM

Thursday, March 01, 2007

Latest Developments on Bush Changes to the Regulatory Process

OMB Watch has created a new web center to be the one-stop source for news and developments on President Bush's recent amendments to Executive Order 12866. The web center will be frequently updated with fresh insights, news from Capitol Hill, and links to media coverage.

Public Citizen Urges Congress to Make Cars Safer for Kids

Yesterday, Joan Claybrook, president of the public interest group Public Citizen, testified before a Senate subcommittee on vehicle safety for children. Claybrook urged Congress and the National Highway Traffic Safety Administration (NHTSA) to improve vehicle safety in an effort to reduce the number of children killed in vehicle related accidents — currently about five per day.

Claybrook also chided the Bush administration for renominating Susan Dudley to be the White House's regulatory czar. As OMB Watch has pointed out numerous times (here, here, and here), Dudley's views are not consistent with those of the public and her installation would likely cause unprecedented rollbacks in health and safety regulations.

Read more about Claybrook's testimony here.



Posted by Matt Madia, 09:48:42 AM