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New budget supports plan for importation of drugs

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.” However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health ... Read More

Peanut Corp. halts its Texas operations as FBI joins investigation

has shut its Plainview, Texas, plant as federal and state officials continue their investigations into the questionable practices that caused a national salmonella outbreak, spurred one of the country’s largest food recalls in history, killed 8 people, and sickened hundreds more. The Peanut Corp. voluntarily shut down its Texas operations after lab tests indicated the presence of salmonella bacteria in some sample products, according to the Texas Department of State Health Services. The Texas plant, operated as Plainview Peanut Company, LLC, produces peanut meal, granulated peanuts, and dry roasted peanuts. None of the possibly contaminated products appear to have reached ... Read More

FDA scientists say their agency is corrupt and broken

A group of scientists at the Food and Drug Administration has sent a letter to President-elect Obama and his transition team, urging a clean-up of the government agency. The letter says that widespread mismanagement and incompetence in the agency have “placed the American public at risk.” The six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal. “The scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at ... Read More

FDA approval of medical devices was rushed and incomplete

A group of FDA scientists recently sent a six-page letter to Barack Obama’s transition team venting consternation over their agency’s corruption and mismanagement. It’s not the first time FDA scientists have sought the help of Washington, pleading for a shakeup, but the number of complaints and the overall tone of the latest letter indicate agency insiders are eager to grab some of the new President’s much promised change. And change is apparently what the FDA needs the most. On Thursday, the Government Accountability Office (GAO) said that from 2003 to 2007, the FDA cleared 228 medical devices for the market ... Read More

Torti named interim commissioner of FDA

FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News. Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story. Last year more than 80 Americans died and hundreds more became ill ... Read More

roof crush safety delays may be good for consumers

An activist and advocate for higher automobile roof strength standards believes that the federal government’s latest delay will ultimately benefit the consumer. As we have reported in the past, the National Highway Traffic Safety Administration (NHTSA), a branch of the Department of Transportation, decided in 2005 to boost its archaic standards for roof strength, issuing a deadline of mid-2008 to accomplish that. However, when June 2008 arrived, the NHTSA said it wasn’t ready and deadline was moved back to July. Then to October. Then to December. Now to April … Paula Lawlor, the founder of People Safe in Rollovers Foundation, ... Read More

Consumer groups, institute team up to urge FDA reform

The National Academies of Sciences Institute of Medicine, the Consumer Federation of America and the Center for Science in the Public Interest have joined together to urge the incoming Obama administration to address food safety issues that have plagued the FDA in the past few years. However, the Institute of Medicine and the consumer groups disagree on the legalities, according to Flesh and Stone. According to the report, the Institute of Medicine issued a statement recommending the USDA’s Food Safety and Inspection Service and the food safety activities of the FDA within HHS should be unified. The consumer groups argue ... Read More

FDA commissioner announces plans to resign next month

The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office. Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year. The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots ... Read More

Daschle likely to inherit agency rife with issues

President-elect Barack Obama has made no formal announcement as yet, but it appears likely that Sen. Tom Daschle will be appointed Obama’s choice for Health and Human Services secretary, according to The Federal Times. If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China. The FDA, struggling with low staff levels, is gradually hiring ... Read More

Candidates review reimportation of prescription drugs

Recent scares of tainted medicines and goods from foreign countries, such as contaminated batches of heparin from China, have spurred presidential nominees Sen. Barak Obama and Sen. John McCain to review their support for individuals to import cheaper drugs from other countries, Reuters/Boston Globe reported today. According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject. Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of ... Read More