House Energy and Commerce Democratic leaders floated a discussion draft of import safety legislation Thursday that makes a host of changes from an earlier version to allay some interest-group concerns and worries within their party — as well as respond to a recent drug scandal.
The committee plans to have hearings on the draft in the next few weeks with a markup shortly after, according to a committee memo.
The first hearing is scheduled for Thursday and will focus on the food and cosmetic provisions.
“The discussion draft raises challenging policy questions, and we anticipate a vigorous debate on the issues,” wrote Energy and Commerce Chairman John Dingell, Health Subcommittee Chairman Frank Pallone, D-N.J., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich.
Most notably, the chairmen kept a fundraising system for food safety and drug safety efforts at FDA but changed what was a user fee to a registration fee and expanded its reach.
The fee originally charged importers per line item, but the new system levies an annual $2,000 fee on food facilities and an undetermined fee on drug firms domestic and foreign when they register with FDA.
The registration fee also fans out to medical device manufacturers, for which the amount of the fee also is undetermined, and cosmetics companies at $2,000 a year. All importers would have to register and pay an annual fee.
Consumer groups proposed a registration fee in lieu of the user fee. Some were uncomfortable with the user fee because it can create the appearance of a conflict of interest.
The food industry, represented by the Grocery Manufacturers Association, opposes both fees. GMA did not respond to inquiries on the draft, and neither did the Advanced Medical Technology Association, which represents device makers.
Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said his group has not taken a position on the bill, but emphasized Congress should increase appropriations for the agency.
Johnson also suggested that a risk-based approach to inspections could help FDA “target its limited inspection resources and represents a reasonable approach to helping minimize risks to American patients.”
The earlier version of the bill limited food imports to ports near one of FDA’s 13 testing labs. The provision was widely panned, even by fellow Democrats.
The discussion draft would allow food companies to get certified by FDA-accredited organizations, and firms that are not certified would be the only ones subject to a limited port rule.
The bill would require inspections of foreign and domestic food facilities every four years, and allows FDA to accredit third-parties to conduct inspections.
FDA would be required to inspect foreign and domestic drug and device firms every two years, and would be required to inspect a firm before a product could go on the market. The latter provision stems from the recent heparin scandal in which the contaminated blood thinner killed 62 people. FDA never inspected the Chinese manufacturer of heparin’s active ingredient.
For future crises, all drug, device, food and cosmetic facilities would be assigned an identification number to help FDA track the product back to its manufacturer.
Drug and device makers also would be required to include country-of-origin labels on their products. Only food companies were required to produce country-of-origin labels in the previous bill.
The first iteration of the bill granted FDA the power to recall tainted food, and the new version would give the agency recall authority for drugs as well.
This article appears in the April 19, 2008 edition of NJ Daily.