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



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 (Note: The story refers to the proposal as "rules" but it is actually "draft guidance" which, unlike rules/regulations, does not carry the force of law.)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 There are pros and cons to the draft guidance.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

Wednesday, March 21, 2007

According to BNA news service (subscription), House members grilled an Occupational Safety and Health Administration official as to why OSHA has only addressed the danger of a pandemic flu outbreak with guidance memos, instead of regulation. Unions and Congressional members have asked for a temporary standard to protect health care workers. Since no flu strain presents danger in America, the official claims, the agency cannot expedite regulation.

I'm no epidemiologist, but I'm fairly certain pandemics do not announce their arrival nor move in an orderly and predictable fashion. As usual, the tangled mess that is the federal regulatory system has blocked a crucial rule.

The big story of the day is a U.S. Chemical Safety and Hazard Investigation Board report which faults OSHA for the BP oil refinery explosion in Texas City in 2005. The report finds, despite repeated fatal accidents over the years, OSHA failed to conduct adequate safety inspections at the plant. The 2005 blast killed 15.

Read more from The Pump Handle here.



Posted by Matt Madia, 02:50:23 PM

Tuesday, March 20, 2007

Consumer Protection Agency Reaches out through Email Campaign

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

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