FDA Spot Check of Imported Drugs Finds Many Are Unapproved for Use in the U.S.

In a spot check of imported prescription drugs conducted this summer, FDA and customs officials found that 88% of the drugs were not approved for U.S. use, agency officials said Monday, the New York Times reports (Harris, New York Times, 9/30). Officials examined 100 packages per day for three days in July and August at mail centers in Miami, New York and Carson, Calif. Customs officials chose packages from countries "known to ship drugs internationally," according to Dow Jones/Wall Street Journal. Canada accounted for nearly 16% of the packages, India accounted for 14% and Thailand was the source of almost 14% (Middleton, Dow Jones/Wall Street Journal, 9/30). Other countries included Brazil, China, Mexico, Peru and the Philippines. The Times reports that because customs officials chose packages from certain countries, they "might have biased the survey in favor of packages more likely to contain counterfeits" (New York Times, 9/30). Of the 1,153 packages inspected -- some of which included more than one drug -- 1,019 contained unapproved medications. The FDA considers drugs unapproved if they are not produced in agency-inspected plants and are not sold with FDA-approved labeling and directions (Dow Jones/Wall Street Journal, 9/30). According to the spot check, packages included counterfeit drugs, drugs approved for use in animals but not in humans, drugs that have dangerous interactions or side effects, drugs that have been withdrawn from the U.S. market and narcotics, officials said (Schmid, AP/Las Vegas Sun, 9/29). The FDA did not conduct chemical tests on the drug samples but rather used "visual inspections" to decide whether they met safety guidelines, according to FDA Senior Associate Commissioner William Hubbard. Bush administration officials described the drugs as "illegal and potentially dangerous" and concluded that "shipments often contain dangerous unapproved or counterfeit drugs that pose potentially serious safety problems," the Washington Post reports (Connolly, Washington Post, 9/30). No legal action will be taken against individuals who ordered the medications, but the packages will be detained at customs, and narcotics will be sent to the Drug Enforcement Agency, FDA Assistant Commissioner Steve Niedelman said.

Implications for Reimportation
Hubbard said the FDA conducted the spot check in response to queries from congressional committees about the safety of medications imported into the United States from foreign countries (AP/Las Vegas Sun, 9/29). The FDA's "stepp[ed] up enforcement" comes as "a growing number of governors say they intend to defy federal regulators and purchase lower-cost drugs from Canada," the Post reports (Washington Post, 9/30). This month, Illinois Gov. Rod Blagojevich (D), Iowa Gov. Tom Vilsack (D) and Minnesota Gov. Tim Pawlenty (R) each announced separate plans to examine programs to reimport U.S.-made drugs from Canada for state employees and residents (Kaiser Daily Health Policy Report, 9/26). In addition, Springfield, Mass., Mayor Michael Albano recently enrolled more than 1,100 city employees in a plan to purchase drugs from Canada. On a federal level, lawmakers are considering a measure sponsored by Reps. Gil Gutknecht (R-Minn.) and Rahm Emanuel (D-Ill.) that would allow the reimportation of drugs from several industrialized nations if the drugs met safety guidelines. The measure is an amendment to the House Medicare reform bill (HR 1).

Reaction
Hubbard said that the Gutknecht-Emanuel bill would "open the floodgates to many more [potentially dangerous] drugs and encourage people to go buy drugs no one had any regulatory oversight over." FDA Commissioner Dr. Mark McClellan said the spot check shows that imported medications are not becoming "safer or more reliable," adding that state or federal efforts to reimport drugs "would increase the flow of these unapproved drugs" (Washington Post, 9/30). Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that allowing reimportation "makes it much more difficult for patients to get safe medicines." But Gutknecht said, "The FDA's blind refutation of fact and its duplicity in making safety claims are predictable and pathetic" (New York Times, 9/30). He added, "Interpreting [FDA officials'] actions regarding the outrageously high cost of prescription drugs for Americans, one might be led to think their mission is to protect the well-being of pharmaceutical manufacturers" (Washington Post, 9/30).

Massachusetts Officials Oppose Springfield, Mass., Plan
Officials at a Massachusetts commission hearing for oversight of municipal funds criticized a request by Albano that the city's pension fund divest drug stocks to "protest high U.S. prescription prices," the Boston Globe reports. Albano has asked the Springfield Retirement Board to sell $6 million in stock from Johnson & Johnson, Pfizer, Eli Lilly, Merck and other drug firms. However, Joseph Connarton, executive director of the Public Employee Retirement Administration Commission, said that plan is not advisable, as the city's pension fund lost 13.3% of its value in 2002. Massachusetts Treasurer Timothy Cahill on Monday said that Albano's proposed divestiture is a "bad idea," adding, "Everyone has to be careful of taking a political direction on investment decisions" (Rowland, Boston Globe, 9/30).

Newark Star-Ledger Examines State Licensure for Rx Distributors
A "recent surge in counterfeit medications" highlights potential problems with New Jersey's system to license drug distributors, the Newark Star-Ledger reports. In New Jersey, 910 companies are licensed by the state Department of Health and Senior Services to distribute medications or other medical supplies, but the registration process they go through is "riddled with holes," and state health officials "rarely conduc[t] inspections and cannot track the activities of the distributors or their executives," according to the Star-Ledger. Of the 910 companies licensed as pharmaceutical wholesalers, only 135 companies detailed plans to distribute drugs when they registered with the state, and it is not known how many of the companies are "actively" distributing medications, the Star-Ledger reports. Carmen Catizone, head of the National Association of Boards of Pharmacy, said, "Given what the FDA is telling us about counterfeit drugs, it's very important for states to look at how their wholesalers are registered." James Blumenstock, acting deputy commissioner for public health protection and prevention at the state health department, said, "If [counterfeit drugs are a] fresh problem, then everyone has to take another look." According to the Star-Ledger, many other states also are not scrutinizing activity of drug wholesalers (Silverman, Newark Star-Ledger, 9/29).

Broadcast Coverage
NPR's "All Things Considered" on Monday reported on importing medications. The segment includes comments from Hubbard; Scott Kirkland, co-owner of Rx of Canada; and MaryAnn Mihychuk, minister of the Manitoba Department of Industry, Trade and Mines (Horsley, "All Things Considered," NPR, 9/29). The full segment is available online in RealPlayer.

The program also reported on how federal and provincial price controls make prescription drugs less expensive in Canada than in the United States. The segment includes comments from Elmer Blankenship, president of the Indiana chapter of the Alliance for Retired Americans; Gutknecht; Steven Schondelmeyer, a professor of pharmacy at the University of Minnesota; and PhRMA spokesperson Jeffrey Trewhitt (Rovner, "All Things Considered," NPR, 9/29). The full segment is available online in RealPlayer.