Import Contamination Risk Looms Larger For OTCs, Ex-Regulators Say

Over-the-counter drugs made with imported ingredients are at greater risk of contamination than prescription products, experts told a House panel on Nov. 1.

"Oversight of OTC drugs ... at the border is even less rigorous than that for Rx drugs," Carl Nielsen, former import operations and policy director in FDA's Office of Regulatory Affairs, said during a hearing on drug import safety before the House Energy and Commerce Oversight and Investigations Subcommittee.

Nielsen said because of the number of foreign OTC drug firms and FDA's lack of resources, its frequency of inspecting firms "may range into several decades."

"The number of foreign ... firms related to OTC drugs could be several thousand, maybe tens of thousands or more, above the Rx industry. They simply are not on the radar as they are not funded in the ORA work plan," he said.

However, Subcommittee Chairman Bart Stupak, D-Mich., said FDA does not provide sufficient information on the number of foreign operations it must inspect in order for Congress to increase funding.

Stupak said previous congressional hearings as well as Government Accountability Office investigations have determined there is insufficient information on FDA's foreign inspection demands to determine whether to increase spending in that area.

"For almost three months our committee and the GAO have repeatedly asked the FDA for the number of foreign firms the agency is supposed to be inspecting overseas and where they are located. For three months the FDA has on 10 different occasions provided numbers ranging from 2,100 to 13,800 foreign firms," he said.

"I am not convinced FDA can accurately calculate the number of foreign firms they should be inspecting," Stupak added.

According to the Synthetic Organic Chemical Manufacturers Association, which filed a ¹ citizen petition in September 2006 requesting FDA tighten inspections of foreign suppliers, the number of foreign facilities providing ingredients or finished products is not only the obstacle to ensuring the safety of imports.

Risks of adulterated ingredients being provided by foreign firms are greater to all drug products because FDA is not required to inspect their operations as often as it must inspect domestic businesses, SOCMA said.

However, the risk grows for some OTC products because FDA is not required "at all" to inspect foreign facilities that manufacture ingredients for products regulated under the agency's monograph process, the organization told "The Tan Sheet."

The general counsel for SOCMA's Bulk Pharmaceutical Task Force, John Dubeck, told the subcommittee many active pharmaceutical ingredients made in foreign facilities are rarely inspected by FDA.

"A drastic and dramatic overhaul of FDA's approach to the risks posed by foreign manufactured drugs is long overdue," said Dubeck, of Washington-based Keller and Heckman.

SOCMA proposes FDA cease "separate prioritizing facilities for inspection based on whether they are domestic or foreign," he said.

"If there are 100 foreign facilities with higher risk profiles than the highest risk-ranked domestic firm, the American consumer is ill-served unless those 100 foreign facilities are inspected before the domestic firm," Dubeck added.

Lynne Jones Batshon, executive director of SOCMA's task force, told "The Tan Sheet" U.S. firms are losing business to foreign competitors, and domestic firms are moving their manufacturing operations overseas because ingredient suppliers in other countries work with the advantage of fewer inspections and other enforcement measures by FDA. "It creates an uneven playing field," she said.

Energy and Commerce Chairman John Dingell, D-Mich., has introduced legislation to improve food and drug import safety. The Food and Drug Safety Import Act, H.R. 3610, would authorize user fees to be directed at hiring more FDA inspectors and other officials for import analysis in the U.S. and abroad.

- Malcolm Spicer ([email protected])