FDA Proposes Returning Mailed Foreign Rx Drug Shipments
Following this week's launch of an FDA investigation of counterfeit drugs found in American pharmacies, FDA officials yesterday recommended that "all but a trickle" of small foreign prescription drug shipments found by U.S. Customs Service agents at mail-inspection sites be returned, the Wall Street Journal reports. Although the FDA prohibits importation of prescription drugs by anyone other than the manufacturer or its distributors, the agency has the authority to grant exceptions for seriously ill patients so they can receive drugs that are unavailable in the United States. However, increased Internet sales of prescription drugs have exceeded the FDA's ability to enforce the rules. According to customs officials, most of the shipments are intended for people looking to skirt U.S. drug laws, not terminally ill patients (Lueck, Wall Street Journal, 6/8). FDA policy calls for customs agents to detain packages that appear to contain prescription drugs until the shipments are inspected by an FDA official. However, a survey by the FDA and the U.S. Customs Service found that "overwhelmed" customs agents release many packages after X-rays have shown they "probably contain medications." The Customs Service estimates that 90% of imported prescription drugs do not meet entry requirements. In testimony before the a subcommittee of the House Energy and Commerce subcommittee, FDA officials made the following recommendations:
- Custom officials would "return to sender" prescriptions drugs shipped by mail.
- Over-the-counter medication would also be returned.
- A "very narrow" exception would be made for "seriously ill" patients using medication not approved in the United States.
- U.S. citizens would continue to be permitted to bring in up to 50 doses of an unapproved drug for personal use (MacDonald, Hartford Courant, 6/8).
William Hubbard, senior associate commissioner at the FDA, said that the agency has asked HHS Secretary Tommy Thompson to approve the recommendations, and if he does, the issue would go before Congress (Wall Street Journal, 6/8). FDA officials said the agency was "uncertain" about its authority and would "prefer" that Congress approve the proposals by "codifying it into law" (Hartford Courant, 6/8). Hubbard said, "We need to be able to make a blanket assessment that these things are not safe for American consumers and should be turned back." While several committee members "voiced their support" for the proposal, Rep. Bart Stupak (D-Mich.) said the FDA could make changes quickly without congressional approval. But Hubbard said the FDA would like to reduce the amount of paperwork required to return shipments, which would require a change in current law (Wall Street Journal, 6/8).
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