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Weekly UpdatesThe House Committee on Energy and Commerce soon will launch investigations of the agency's oversight of FDA's handling of Good Clinical Practices (GCPs), according to a Washington attorney with inside knowledge.
Daniel Kracov, partner with the Washington law firm Arnold & Porter, told the told a Center for Business Intelligence (CBI) conference in Washington July 31 that GCP "has been an issue with Commerce Committee investigators, too. I think we'll see more about that as well, particularly issue of the extent companies are maintaining GCPs."
Kracov said the oversight investigation will focus on FDA's field force and field labs, too. FDA Aug. 1 canceled its plans to close seven of the 13 regional labs due to congressional fire.
Members of Congress have called the plan misguided and questioned whether it would save money, as FDA has claimed. Worse, they said, is the risk it would harm food safety.
"FDA's ill-conceived decision to close seven of its 13 laboratories likely would expose American consumers to even more danger from unsafe foods, particularly imports," said Rep. Bart Stupak, (D-MI) at the onset of a hearing of the House Committee on Energy and Commerce subcommittee on FDA and food safety. Imports from China, in particular, have come under scrutiny. Chinese-made ingredients have been linked to deadly pet food ingredients mixed with industrial chemicals nd snack food seasonings contaminated by salmonella.
"We know that we are vulnerable to harm from abroad where rules and regulations governing food production often are more lax than they are at home," said Rep. Marsha Blackburn, (R-TN)., in raising the prospect of terrorists tampering with imports entering the U.S. food supply.
Investigations also are forthcoming, Kracov said, regarding FDA's oversight of foreign inspections and active pharmaceutical ingredients (APIs).
"China issue has kicked off a large investigation both in foods but also in the drug area." He said the Committee's "investigative staff is going to China" to look at products coming in to the U.S. "This will likely lead to legislation," the attorney added.
House Oversight and Government Relations Committee Chairman Henry Waxman (D-CA), who also is a senior member of the Commerce Committee, told the meeting his panel is not examining APIs, specifically, "but we feed into them," referring to the Commerce Oversight & Investigations Subcommittee, which is chaired by Rep. Bart Stupak (D-MI), a long-time critic of the drug industry.
Waxman noted the reauthorization of prescription drug user fees--FDA Revitalization Act (FDARA)--was passed by the House on the suspension calendar, meaning there were no chances for amendments. He said "one thing will be for FDA to use user fee dollars for post-marketing surveillance of the drug. I believe that would include ensuring manufacturers are following GMPs as well as monitoring the side effects of the drugs used. But I don't know how far that money will go."
Waxman said the "hope is a dimming" for user fee reauthorization to allow "biosimilar" drugs in the U.S. (a.k.a., generic biologics) and weaker rules on patients importing drugs from Canada, Mexico and other nations where prices are lower.
Traditionally, user fees were allowed to finance pre-approval inspections, but not GMP audits, which had to be funded out of regular FDA appropriations. However, there have been numerous articles in "The Washington Post" and other media about the decline in FDA compliance inspections, so there could be efforts when the user fee bills comes up for a final vote--now slated for September--to include language to allow fees for GMP audits. Krakov also said FDARA "will emphasize drug safety, post-marketing surveillance and distribution controls."
The prospect of greater GMP oversight by Congress comes on the heals of a major shakeup in China's regulation of food and drugs, notably the execution of its former director of the Chinese equivalent of FDA for taking bribes.
In addition, China is cutting export incentives on APIs, thus leading to higher prices of bulk drugs. According to a July 23 article in "PharmAsia News," China's Ministry of Finance and the State Administration of Taxation cut the tax rebate rate 13% to 5% for some active pharmaceutical ingredients as of July 1. As a result, prices of most APIs have already gone up.
These include antipyretic and analgesic categories such as paracetamol, aspirin, ibuprofen, quinolones of ciprofloxacin, levofloxacin, citric acid and cortical hormones, perindopril and losartan categories, synthetic statins and sulfonamides. In addition, antibiotics for animal use and plant extracts also came under the cut.
At a press conference last month, a Ministry of Finance official told reporters that the reason for the cuts was excessive trade surplus and excess liquidity.
According to the China Chamber of Commerce for Import and Export of Medicines and Health Products, API exports reached $4.155 billion during the first four months of 2007, up 22 % over the same period last year. The major export markets are the U.S., India, Japan, Germany and the Netherlands.
By BioResearch Compliance Report Staff
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