Sen. Kennedy’s Foreign Inspection Bill Gives FDA More Flexibility Than House

House and Senate Democrats are taking similar approaches in regard to invigorating FDA's ability to oversee foreign manufacturing facilities. But some fundamental differences and Republican concerns suggest that the issue will likely not be resolved until at least the next Congress.

Both Sen. Ted Kennedy, D-Mass., and Rep. John Dingell, D-Mich., who has prepared a discussion draft of an FDA Globalization Act, are considering fees on industry to pay for more inspections of drug producers, a registration system for importers, country-of-origin labeling for drugs and their active ingredients, and FDA authority to order drug recalls, to destroy unsafe drug imports and to assess civil monetary penalties for violations of drug safety requirements.

Neither Dingell's discussion draft nor a Kennedy options paper specifies the amount of a drug producer registration fee, but the former calls for a $10,000 annual registration assessment on importers (¹ (Also see "Foreign Drug Inspections Would Be Funded By Registration Fees In Draft Bill" - Pink Sheet, 21 Apr, 2008.), p. 21).

Kennedy's options include an electronic pedigree for drug ingredients. A separate bill setting e-pedigree requirements for drugs is under review by Dingell's Energy and Commerce Committee, but the Chairman seems disinclined so far to fold it into his legislation (² , p. 8).

A bill that emerges from Kennedy's Health Committee also could set more requirements with regard to quality assurance and provide authority for FDA to exchange confidential information with foreign government officials (see chart: " ³ Going Global, Senate Style: Kennedy's Foreign Inspections Ideas ").

Kennedy's Risk-Based Approach

Another key difference between Kennedy's and Dingell's approaches centers around how much deference to give FDA when establishing its new authorities. Kennedy's legislative proposal would enshrine the agency's "risk-based" inspection approach, under which the agency targets facilities that appear most likely to have problems. Dingell, though, has dismissed the risk-based approach as a declaration by FDA that it would "only do the minimum" (⁴ (Also see "FDA’s Price Tag For Foreign Facility Inspections Tops $225 Million" - Pink Sheet, 5 May, 2008.), p. 5).

While Dingell has directed most of his ire about the state of oversight of foreign facilities toward FDA, a recent hearing featured a grilling of Baxter about the quality of its inspections. The company emphasized the new steps it was taking to ensure the quality of its products (see ⁵ (Also see "Baxter’s War Games: Post-Heparin, Scientists Consider Supply Chain Threats" - Pink Sheet, 12 May, 2008.)).

While Kennedy's options paper was created without the input of the Health Committee's ranking member, Michael Enzi, Wyo., he seems to share Kennedy's belief that requiring a massive FDA inspection undertaking is not necessarily the best approach. "We cannot inspect our way to safety," Enzi said at an April 24 hearing.

Enzi said his priority this year is food safety. The FDA Amendments Act gave FDA broad authorities to deal with safety issues and "we should give FDA the time to fully utilize those new authorities and evaluate their effectiveness," he suggested.

However, he added, there are areas for improvement "on which we could quickly reach agreement." Those areas, which are being explored, are likely to be the foundation of any legislation as Congress strives to take action in the wake of contaminated heparin.

Bipartisan discussions have begun in the Senate Health, Education, Labor and Pensions Committee, where Chairman Kennedy is seeking input from members on what new duties and authorities to give FDA and how to pay for expanded agency activities. On the House side at least, Republicans are vocal about their concerns over additional user fees.

The development of the legislation on oversight of foreign facilities is proceeding markedly differently from how the last major piece of FDA legislation moved through Congress. With FDAAA, although the legislation ultimately wound up with the House bill's name on top, the structure of the act reflected mostly the joint thinking of Kennedy and Enzi, who worked closely on numerous versions of the bill over several years.

For the globalization act, the House is taking the lead and Kennedy has taken his initial steps without Enzi. Dingell was developing the concepts even as the legislative spotlight was still on FDAAA. While the heparin scandal has given the issue new urgency, Congress' limited election-year calendar suggests that the legislation may not come to fruition this year.

- Cathy Dombrowski ([email protected])