Bill seeks overseas oversight for FDA

-Politico, DC

04/01/2008 -  Concerns were raised over the blood thinning drug Heparin after the Food and Drug Administration announced that it caused an allergic reaction in more than 700 people, some of whom died.

According to a report, a dietary supplement had been added to the drug at a Chinese plant that was never inspected by the FDA.

"We need to have a much more thorough investigation of imports from China on of all products, but especially pharmaceuticals and drugs that can be a matter of life and death

What do you get when you mix a contaminated Chinese blood thinner, lead-tainted Indian cosmetics and life-threatening Honduran cantaloupes? 

A lot of nervous lobbyists. 

As Congress works to craft new legislation to give the Food and Drug Administration increased power to oversee imports, advocates for corporations and public health groups are watching closely. 

At stake is not only how much new power the FDA will have but also who will pay for it. 

The new bill will be a modification of last year’s legislation introduced by House Energy and Commerce Committee Chairman John Dingell (D-Mich.). It did not move then, but industry groups have since been busily formulating their own counterproposals. 

“Many flowers have bloomed since Chairman Dingell laid down a healthy bed of soil in which we could all plant our seeds. It is springtime, and hopefully we won’t have to wait until fall to harvest,” said Scott Faber, a lobbyist for the Grocery Manufacturers Association. 

The food industry, under a cloud after a series of recalls, is generally supportive of efforts to enhance overseas regulation. Nonetheless, Faber said there are a number of provisions in the old bill that his association wants to change. 

Chief among them is a requirement that industry pay for inspections of facilities overseas. Those fees would “absolutely be passed on to the consumer,” Faber said, adding: “It’s a curious electoral strategy to tax food at a time of record inflation of food prices.” 

The drug industry, most recently stung by the recall of the blood thinner heparin, is keeping its cards close to its chest. The industry’s trade group, the Pharmaceutical Research and Manufacturers of America, declined requests for an interview. But in a statement, the group urged Congress to increase funding for FDA’s oversight — which appears to be a rejection of the industry levy in the Dingell legislation. 

All sides seem to agree the current process is broken. In drug manufacturing alone, it would take the FDA 13 years to inspect each overseas producer at least once, according to the Government Accountability Office. About 80 percent of the bulk substances used by U.S. drug manufacturers come from overseas, many from China and India. 

Last fall, GAO’s director of health care, Marcia Crosse, testified about faulty FDA record keeping and a weak overseas inspection program. “Until FDA responds to systemic weaknesses in the management of this important program,” she said, “it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized and safe.” 

The latest scare — the contaminated blood thinner heparin, which has been linked to 19 deaths and hundreds of injuries — will be the subject of an upcoming inquiry by the House Energy and Commerce Oversight and Investigations Subcommittee.

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