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Tuesday, July 31, 2007

FDA Panel Weighs in on Avandia

Yesterday, Dr. David Graham of the FDA recommended to a panel of scientific advisors the diabetes drug Avandia be pulled from the market. Studies have shown the drug may lead to an increased risk of heart attacks.

In a 20-3 vote, the panel agreed the drug increases the risk of heart attacks, according to The New York Times.

But the panel did not concur with Graham's assessment. The panel voted 22 to 1 to leave the drug on the market. Instead, the panel recommended the drug's packaging include warnings of the potential side effects. FDA will make the final decision on the drug's fate and may or may not choose to adopt the panel's recommendations.

On a related note, NPR reported a good story this morning on post-market drug safety. Dr. Bruce Psaty of the University of Washington describes how FDA and drug makers monitor the safety of drugs after they are approved for consumer use and why these processes are often insufficient. Listen to it here.



Posted by Matt Madia, 09:56:14 AM



Monday, July 30, 2007

Questions Remain on Bush Changes to the Regulatory Process

As of July 24, agencies are to be in full compliance with President Bush's recent changes to the regulatory process. But the American people remain in the dark in knowing how these changes will influence the way our government operates. A new analysis by OMB Watch reiterates our concerns with the changes, identifies the many questions that remain, and describes Congress's efforts to mitigate their impact through oversight hearings and proposed legislation.

Read the analysis: E.O. 13422: Unanswered and Unaccountable



Posted by Matt Madia, 09:59:16 AM



Monday, July 23, 2007

USDA Sends Farm Subsidies to Deceased Landowners

Think federal regulation is just government wasting your tax dollars to meddle in your business? Well, a new GAO report suggests that lax regulatory oversight has led the U.S. Department of Agriculture (USDA) to send over one billion dollars in farm subsidies to deceased farm owners.

According to the report, issued at the behest of Sen. Charles Grassley (R-IA) of the Senate Finance Committee, the department continued mailing checks in the name of dead estate owners with little or no investigation, failing even to cross-reference Social Security numbers with other databases. From a sample of only 181 cases from 1999 to 2005, GAO found that officials failed to review 40 percent of payment subsidy requests and relied solely on businesses and family members to alert the agency of the deaths.

To make matters worse, the GAO report points out that in many cases, already wealthy corporate-owned farms often received these payments, and often the sums of these payments exceeded the USDA's own yearly-allotted limits to individuals. Grassley is requesting that the IRS investigate these payments to see if these estates, normally subjected to higher taxes, properly accounted for that money in tax reporting.

In its defense, the USDA cited insufficient staffing and competing priorities as the reasons for failing to conduct reviews. One can only wonder how much tax-payer money would've been saved if a few extra regulatory officials were hired. Maybe proper regulation isn't so wasteful after all.



Posted by Kyle Hatzes, 05:45:23 PM



Wednesday, July 18, 2007

Senate Examines Chinese Imported Product Safety

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.



Posted by Kyle Hatzes, 04:58:01 PM



Congressman Asks GAO to Examine Regulatory Process

Rep. Henry Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, has requested a Government Accountability Office report on the regulatory process.

Waxman would like GAO to focus on the analytical and review requirements which often delay rulemakings. Waxman has specifically asked GAO to report on the panoply of analyses agencies must perform for every rule they consider, how these analyses are delaying rules, agencies' relationship with the White House Office of Information and Regulatory Affairs, and the transparency of the White House review process.

A final report is a long way off. But considering the scope of Waxman's request, this report could prove to be a comprehensive and immensely valuable. Hopefully, the report will describe why the federal regulatory system is so broken and why agencies often seem to respond to political considerations rather than public need.

Read Chairman Waxman's letter to GAO



Posted by Matt Madia, 11:13:35 AM




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