Continuing his trend of nominating people with ties to business and industry for regulatory positions, President Bush has nominated Michael Baroody to head the Consumer Product Safety Commission (CPSC). Baroody, an anti-regulation fanatic, has spent his career as an industry lobbyist and is an executive for the National Association of Manufacturers (NAM), one of the most powerful industry trade groups in the country. In short, Baroody has spent his career fighting against reasonable product-safety measures, and a slew of consumer watchdogs are, shall we say, not pleased.

According to a new report by Public Citizen, a national, nonprofit consumer-advocacy organization, NAM under Baroody’s watch was instrumental in severely weakening the CPSC’s safety guidelines related to the disclosure of hazardous products. “As head of the CPSC, Baroody would be in charge of administering the weakened disclosure guidance his industry association sought, presenting a serious and unavoidable conflict of interest,” said Public Citizen President Joan Claybrook. “Under his authority, consumer and public safety would be at risk, while the companies he represented for years would save millions in future fines.”
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After a relatively quiet couple of weeks, it appears that the scandal surrounding Attorney General Alberto Gonzales and the controversial firings of a group of U.S. attorneys is about to heat up again. Yesterday, the Department of Justice cleared the way for the testimony of former Justice official Monica Goodling after allowing Congress to grant her immunity.

Because the DOJ’s Inspector General Glenn Fine and the head of its Office of Professional Responsibility, H. Marshall Jarrett, are both pursuing their own joint internal investigation, it was unclear whether or not they’d agree to grant Goodling immunity. However, in a letter to Rep. John Conyers, chairman of the House Judiciary Committee, Fine and Jarrett indicated that they understood “the Committee’s interest in obtaining Ms. Goodling’s testimony.” Said Conyers: “I believe obtaining her testimony will be a critical step in our efforts to get to the truth about the circumstances surrounding the U.S. attorney firings and possible politicization in the department’s prosecutorial function.”
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Late last week, the U.S. Food and Drug Administration issued a warning to healthcare professionals and drug manufacturers about the potential presence of diethylene glycol (DEG) in prescription and over-the-counter drugs. DEG is a known poison used in the production of antifreeze and it can be fatal if consumed by humans.

DEG is often added to glycerin as a cost-saving measure for counterfeiters; glycerin is a thick sweetener that is commonly used in liquid medications. “At the present time,” says the agency, “FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.”
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After a risk assessment conducted by five federal agencies, it was determined that there is a “low risk” to human health from eating meat from animals who were given feed contaminated with melamine. Scientists from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), U.S. Customs and Border Protection (CBP), and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) all participated in the investigation.

According to the report, even in the “most extreme risk-assessment scenario,” the level of potential exposure was way below “any level of public health concern.” The team of scientists is now conducting further analysis to determine the effects that melamine contaminated pet food has on animal health. The FDA and USDA plans to create a scientific advisory board of experts to assist in their ongoing investigation.
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This morning, Brazilian President Luiz Inacio Lula da Silva agreed to issue a “compulsory license” to allow a generic version of Merck’s AIDS drug, efavirenz, a move that would override Merck’s patent protection. Brazil’s Health Ministry believes the decision will save the country as much as $240 million because generic alternatives will cost less than half as much as Merck’s branded drug. It is believed that 75,000 Brazilians currently use the drug.

In a speech defending his decision, President Silva said, “It is not possible for anyone to get rich with the misery of others. In a choice between our trade and our health, we will take care of our health. We are taking an important step that is valid for this drug, but also for as many others as are necessary.”
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Seeking ways to reduce the soaring costs of prescription drugs for American consumers, the Senate approved their drug-reimportation provision for a final vote. That final vote is slated to occur at some point next week, even as President Bush has threatened to veto the measure.

Senators supporting the measure believe it would save consumers as much as $50 billion over the course of a decade. The legislation would allow for the reimportation of prescription drugs from Canada and several other nations, and the drugs would be available to both individual consumers and commercial distributors. The drugs would need to come only from FDA-approved pharmacies and facilities. However, opponents of the idea say that it would be too difficult for the U.S. Food and Drug Administration (FDA) to ensure the safety of the reimported drugs.
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Outraged protesters set up camp in front of the U.S. Embassy in Bangkok today in response to the U.S. government’s renewed efforts to crack down on generic drugs being sold in Thailand. The protests are in response to a move made earlier this week by the U.S. Trade Representative Office (USTR), which placed Thailand on the Priority Watch List (PWL) for intellectual-property-rights infringement.

“On Monday, the USTR released its annual 301 Report, which includes a Watch List of countries that the USTR believes are threats to the global drug industry,” explain the advocates at the AIDS Healthcare Foundation (AHF). According to the AHF, Thailand is merely exercising “its World Trade Organization-granted rights to protect public health.”
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Last month, a man by the name of Jerry Miller was exonerated of rape charges after DNA evidence had proved his innocence. Only one problem: He had already served nearly 25 years in prison. Miller’s exoneration marks a dubious milestone in criminal justice, as he was the 200th wrongly convicted individual to be exonerated by DNA evidence in the United States.

The nonprofit legal group known as the Innocence Project has chosen to commemorate this milestone. The Innocence Project bills itself as a “national litigation and public-policy organization dedicated to exonerating wrongfully convicted people through DNA testing and reforming the criminal-justice system to prevent future injustice.” It is their hope that by calling attention to Miller’s case, they can generate some momentum behind their reform efforts.
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The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately.

The FDA uses the term “suicidality” to describe what they call suicidal thinking and behavior. The new “black-box” label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18 to 24, during the initial stages of treatment, which usually encompasses the first couple of months.
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With the highly controversial Prescription Drug User Fee Act (PDUFA) set to expire this September, a debate is raging through Congress, the U.S. Food and Drug Administration (FDA), the health-care industry, and the pharmaceutical industry about the relative merits of the user-fee program. To some, having drug companies pay user fees to the FDA is a necessary way to make sure the agency has an adequate budget to work with. However, a growing number of critics believe that the system leaves federal regulators beholden to the industry it is supposed to monitor.

An editorial published in this week’s New England Journal of Medicine has explicitly called for the dismantling of the user-fee system. “User fees now account for more than 40 percent of the budget of the FDA division that reviews new drug applications,” writes Dr. Jerry Avorn, a professor at Harvard Medical School. “Colleagues at the FDA have told me of a worrisome side effect of PDUFA: the growing sense that the organization is accountable to the industry it regulates. One FDA scientist who was often criticized for being too concerned about drug-risk data was told by his supervisor to remember that the agency’s client was the pharmaceutical industry.”
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