An FDA scientist has recommended the diabetes drug Avandia be pulled from the market for heightening heart attack risks associated with its use. Dr. David Graham made the recommendation during a meeting of a scientific advisory panel which will consider whether the drug should continue to carry FDA approval, according to the Associated Press.

In May, a study published in the New England Journal of Medicine called attention to heart problems associated with the drug.

The FDA could have prevented this scandal by listening to doctors and scientists who recommended a "black-box" warning on the drug's label, the highest the FDA imposes, in February 2006. Instead, the FDA chose to alienate its own experts from the process, siding with industry-backed data.

Unfortunately, patients who have taken Avandia bear the true cost of regulators' irresponsibility. GlaxoSmithKline is questioning the validity of FDA data with its own, also according to AP. Let's hope that this time FDA stands up for public health.

As we blogged earlier this month, the Consumer Product Safety Commission (CPSC) has been without a quorum since July 2006. This has prevented it from fully addressing all of its responsibilities since January of this year. The agency oversees the safety of thousands of domestic and foreign consumer goods used in homes, schools, and sports.

Life at the agency has become so difficult that one commissioner worries publicly that the agency may not survive, according to an Associated Press (AP) story published today. Commissioner Thomas Moore is quoted as saying that cuts in staffing and budgets have employees worried that the agency may not exist much longer and many are looking for other jobs. The number of full time staff has declined to about 400, half of what it was in 1980.

Both Moore, a Clinton appointee, and Acting Commission Chairwoman Nancy Nord, an appointee of President Bush, support congressional action that could strengthen CPSC's powers and modernize laws related to its functions. Democrats in Congress have proposed legislation to accomplish this and to allow CSPC to function for another six months without a quorum.

The CPSC people have reason to worry. Like the Reagan administration, which sharply cut back staff in the 1980s after businesses complained about the agency, the Bush administration isn't likely to embrace efforts to enhance CSPC's powers. Bush took eight months to nominate Michael Baroody, an industry representative who fought CSPC for years, to fill the current commission vacancy to reach a quorum. It's been two months since Baroody withdrew his nomination in the face of considerable Senate opposition and Bush still hasn't nominated a replacement. Surprised?

You'd think that U.S. Food and Drug Administration (FDA) officials would be willing to listen to their own employees as public confidence in the agency diminishes among a string of regulatory lapses and congressional investigations. However, a BNA report ($) suggests otherwise.

Last week, members from the House Energy and Commerce Committee met with a panel of FDA employees from several district offices to discuss the effectiveness of the agency in keeping Americans safe. At one point, the panel rated the effectiveness of the FDA between 2 to 5, on a scale of 1 to 10 (highest), though they refuted claims that FDA personnel in the field and in the offices were to blame and defended the agency's expertise.

In what is considered a retaliatory move, Assistant FDA Commissioner for Regulatory Affairs Margaret Glavin sent an officewide e-mail claiming that their peers had balked at the performance of FDA personnel. FDA Commissioner Andrew von Eschenbach defended FDA's food safety work but didn't condone Glavin's intimidation in an agency-wide e-mail the same day. According to the report's sources, however, it appears that Glavin grossly misrepresented the intentions of the panel.

Accountability seems to mean little to FDA officials these days. The lack of initiative by top agency officials to confront the issues that face the agency everyday shows a disregard for life-protecting regulation.

More disappointingly, von Eschenbach may have missed his golden opportunity to show true responsiveness to the concerns of his employees, and the welfare of the general public, by listening to the panel and using their testimonies constructively to help improve the agency's effectiveness and rebuild the FDA's tarnished image.

In 2007 alone, Chinese imports have been responsible for a nation-wide tire recall, a ban on five types of seafood containing potentially toxic additives, toys manufactured with lead-based paint, contaminated pet-food, and various other defective goods. In response to these concerns the Senate Committee on Commerce, Science and Transportation held an unofficial meeting today to shed light on why government agencies have been so slow to combat product safety violations.

The panels, consisting of representatives from various federal agencies including CPSC and FDA and numerous health and consumer safety groups like Center for Science in the Public Interest, said that agencies couldn't keep up with the rising rate of imported Chinese goods partially because decades-old laws and statutes govern the regulation of imports. Those imports have quadrupled since 1997.

Chinese manufacturers face loose, often non-existent government oversight. Most do not recognize food and safety standards in the U.S., and they improperly label many of their goods which makes the producer difficult to trace. To make matters worse, importers face weak reprimand from the FDA and CPSC, who lack statutory power to initiate mandatory recalls or levy civil penalties.

Panelists discussed solutions such as newly proposed legislation (the Children's Product Safety Act), increased appropriations for the FDA and CPSC to help these agencies monitor and enforce current and new regulations, and new labeling standards. The CPSC announced a four-step initiative that included holding safety summits and seminars with Chinese manufacturers and modernizing the Consumer Product Safety Act of 1973.

Perhaps most importantly, both sides agree that the issue is pressing and demands a progressive bi-partisan approach to fixing the various regulatory inadequacies meant to safeguard ourselves and our children from harm.

This is a Reg•Watch friendly reminder to President Bush that he has not yet announced a suitable nominee to head the Consumer Product Safety Commission (CPSC). CPSC is an independent regulatory agency responsible for ensuring product safety by promulgating rules and negotiating or forcing recalls.

In May, consumer advocates rightly heralded the withdrawal of the nomination of former industry lobbyist Michael Baroody. But a month-and-a-half later, Bush has not announced a new nominee.

CPSC has been without a commissioner since July 2006, and has been without a voting quorum since January, stripping it of its ability to conduct official business. CPSC may still negotiate recalls but would be unable to force a recall if a situation warranted. The commission has not produced a final rule in almost a year.

The Senate voted to attach to an unrelated bill (S. 4) an amendment introduced by Sen. Mark Pryor (D-AR) which would extend the quorum for six months. However, the bill is stuck in conference negotiations with the House.

The Senate Commerce Committee — which has jurisdiction of CPSC nominees — would be wise to prod the White House on the issue. America needs a fully functioning CPSC. By failing to appoint a CPSC commissioner, President Bush is delaying the work of an important federal regulatory body.

A Los Angeles Times article airs the views of Elizabeth Warren, a Harvard law professor who wants the federal government to do a better job protecting Americans from confusing or misleading financial products.

Warren contends government does a much better job of regulating products like toasters than it does of regulating financial products like mortgages and credit cards. Warren is calling for a financial products safety commission which would operate much like the existing Consumer Product Safety Commission:

If Congress authorized a commission to monitor financial products, Warren said, it could respond more quickly and effectively to product innovations and a changing marketplace.

She said it was likely to result in fewer regulations rather than more.

"This isn't so crazy," she said. "I don't want to get tainted meat or take prescription drugs that are placebos. I don't want to buy toasters that have a 1-in-5 chance of bursting into flames. Regulation protects me from that.

"I think the same, minimal protection should extend to financial products."

The idea may find a receptive audience, thanks to rising consumer debt, soaring delinquencies and mortgage foreclosures.

Regulation, not red tape, is urged [Los Angeles Times]

Today, The Washington Post published a good article by David Brown which discusses Congress's recent efforts to renew the Prescription Drug User Fee Act and to reform drug safety at FDA.

The must-pass legislation will improve FDA's ability to conduct post-market surveillance. While FDA needs more authority in this area, the article rightly points out post-market surveillance is "the regulatory equivalent of chasing the horses after they are out of the barn."

The article also gets to one of the real concerns about the idea of user fees: drug makers are funding the regulation of their own products. The process has let Congress off the hook in funding an essential function of government. In predicting the impact of the legislation, the article states:

it seems likely that heavy reliance on user fees — rather than appropriations by Congress &mdash will continue to be a key feature of pharmaceutical regulation.