Drug import fees totaling $300 million each in fiscal years 2008 through 2012 would be authorized by a food and drug import safety bill being developed by House Energy and Commerce Committee Chairman John Dingell, D-Mich.

The money would pay for additional personnel to conduct more inspections and laboratory testing of drug imports, but the legislation does not specify how many are to be hired.

FDA would be directed to focus the new resources at ports of entry, emphasizing the detection of intentional drug adulteration or misbranding, and on inspecting overseas facilities to ensure the application of good manufacturing practices.

The drug import fees, along with $500 million per year in similar assessments on food imports, would pay for "personnel at both the border and at FDA laboratories to expedite processing and fortifying our food and drug safety system," Dingell explained in an Aug. 3 Dear Colleague letter seeking input on a discussion draft of the legislation.

"Given the risk of this pressing concern, we now have the responsibility to create responsible, risk-based legislation that will protect the American public from tainted imports."

The discussion draft does not specify how drug import fees are to be calculated, requiring only that the fee be assessed on each line item of imported drugs, to be defined by regulation, with the fee not to exceed $1,000 per line item. The fee could be waived or reduced if the amount collected exceeds the cost of inspections.

The ¹ draft bill delivers on Dingell's pledge to follow up on drug and food import safety concerns raised by members of his Energy and Commerce Committee during markup of legislation to reform FDA and reauthorize user fees (² Also see "Counterfeit Drugs, Food Safety Are Expected Focus Of New FDA Bill In House" - Pink Sheet, 2 July, 2007., p. 7).

The conference to iron out differences between that measure, H.R. 2900, and the Senate version, S. 1082, has been delayed until September when Congress returns from its August recess (³ Also see "FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill" - Pink Sheet, 6 August, 2007., p. 19).

More details and stronger FDA enforcement authority over illegal imports of counterfeit drugs are likely topics as committee members devise additions to the draft.

In the Senate, Finance Committee Ranking Member Chuck Grassley, R-Iowa, is urging FDA to improve its safety oversight of foreign-made medicines without waiting for new legislation. Citing its struggles to oversee imported food and drugs, the agency has expressed the need for a new regulatory paradigm for "dealing with the global environment" (⁴ [A#00690180018], p. 32).

An Aug. 8 letter to FDA Commissioner Andrew von Eschenbach from Grassley cites recent reports of inadequate FDA inspections of foreign pharmaceutical manufacturing plants.

"Given the fact that nearly 80 percent of the active pharmaceutical ingredients used in the U.S. are manufactured abroad, this is a significant problem that needs to be addressed immediately," he said.

In addition to requesting information on the operational details and results of FDA's foreign inspections, Grassley asks for agency plans on creating an outpost in India and how FDA is preparing to handle an expected shift in manufacturing facilities to Asia.

Reimportation Debate Reemerges

Counterfeit drugs were the topic of the Pharmaceutical Research and Manufacturers of America's initial reaction to Dingell's discussion draft.

The group is still assessing the details of Dingell's proposal, but Senior Vice President Ken Johnson reiterated the drug industry's opposition to legislation that would widen legal importation of pharmaceuticals.

"If certain importation schemes pass through Congress, counterfeit medicines could flood into our borders ... and put patients' lives at risk," he said in an Aug. 6 statement.

Sponsors of such a scheme - Sens. Byran Dorgan, D-S.D., and Olympia Snowe, R-Maine, and Reps. Rahm Emanuel, D-Ill., and Jo Ann Emerson, R-Mo., - were also active last week, announcing support for their legislation from the National Federation of Independent Business.

The legislators on Aug. 9 released a letter from NFIB stating that their bill, S. 242/H.R. 380, would lower drug costs while creating "specific requirements that ensure that every imported drug meets U.S. safety standards."

That legislation would allow pharmacies, wholesalers and individuals to import lower-cost drugs from other countries (⁵ Also see "Rx Importation Legislation Debate Begins Anew, But Battle Lines Are Familiar" - Pink Sheet, 12 March, 2007., p. 19). Currently, drugs can be imported into the U.S. only by manufacturers from facilities registered with the FDA; individuals can bring personal supplies into the country from Canada.

An attempt by Dorgan to authorize additional imports through S. 1082 was thwarted by a diluting amendment, but the Senate bill retains requirements for putting serial numbers and counterfeit-resistant technologies on packages of drugs marketed in the U.S., and applies them to containers originating domestically, as well as overseas (⁶ Also see "Rx Importation Sinks In Senate, But Leaves Anticounterfeiting Regs In Its Wake" - Pink Sheet, 14 May, 2007., p. 19).

The importation issue will be debated in several other venues once Congress reconvenes; language essentially permitting the practice has been included in several pieces of legislation.

The agriculture appropriations bill adopted by the House would bar FDA from enforcing a ban on imports of FDA-approved prescription drugs. In the Senate, the funding bill for the Department of Homeland Security prohibits the expenditure of funds to enforce an import ban on individuals.

Labs Retrieved

Dingell's bill also addresses the controversy surrounding FDA plans to tighten up its field operations by closing seven of 13 field laboratories and all regional offices. The draft legislation proposes Congressional veto power over such closures.

Before closing or consolidating any of its 13 field laboratories, 20 district offices, or the inspection or compliance functions of those offices, FDA's Office of Regulatory Affairs would have to consult with affected personnel and unions and submit a plan to the authorizing congressional committees and the Government Accountability Office, the draft says.

GAO would evaluate the cost effectiveness of the plan and its impact on the safety of food, drugs and other regulated products and submit a report to the House and Senate committees,

Congress would then have 180 days in which to disapprove the plan. Otherwise, it could become effective.

FDA's Office of Regulatory Affairs temporarily suspended plans to close seven field offices in the wake of a July 31 letter to FDA Commissioner Andrew von Eschenbach from Dingell and Rep. Bart Stupak, D-Mich., chairman of the Energy and Commerce Oversight Subcommittee, opposing that action.

In an Aug. 1 e-mail to ORA staff, Associate Commissioner for Regulatory Affairs Margaret Glavin said the agency has "decided to take another look at our proposed design."

She noted that an interagency working group has been established to promote import safety, and that the delay will allow the agency to address factors such as increasing complexity of products and manufacturing processes, burgeoning imports and the threat of intentional contamination.

The congressmen had charged that the reorganization was aimed at privatizing the agency's food safety oversight functions, citing a proposal by the National Coalition of Food Importing Association to pilot the use of private laboratories to evaluate imports.

FDA Commissioner von Eschenbach said earlier this year that the reorganization would move as many as 100 investigators to field positions (⁷ [A#00690160017], p. 29).

But while the lab closings are on hold, ORA is continuing other parts of its reorganization. Glavin said that changes include implementing a "Science Directorate" to manage laboratory assets for better response to emerging threats.

In changes to Section 703 of the Food Drug and Cosmetic Act dealing with records of interstate shipments, the discussion draft would eliminate language that exempts those providing records from prosecution and exempts carriers that receive, carry, hold or deliver drugs, devices, cosmetics or food from being subject to other provisions of the FDCA.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Inspection Of Rx Imports Would Climb Under Bill Setting $300 Mil. In User Fees

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