Rx DRUG COSTS: Dingell Wary of Recent Import Legislation

      House Commerce Committee ranking member John Dingell (D-Mich.) has raised concerns about recently approved House and Senate measures that would allow pharmacists and wholesalers to import less expensive drugs from other countries, CongressDaily/A.M. reports. The bills would effectively repeal the 1988 Prescription Drug Marketing Act, legislation sponsored by Dingell that gave drug manufacturers the sole right to reimport their products into the United States. While lifting the import ban could provide Americans with cheaper pharmaceuticals, Dingell and other critics fear that the measure will pose a threat to consumers, possibly exposing them to counterfeit or substandard medicines. "I'm opposed to the idea that we should take controls away from the FDA. This is a monument to the bad way of doing things ... We need to observe the committee system to avoid this kind of problem," Dingell said. He recently signed a letter asking House Commerce Committee Chair Tom Bliley (R-Va.) to address the issue in committee. Although the panel has tackled related drug import issues and has blasted the FDA for inadequate enforcement of current laws, most of the members voted in favor of lifting the ban. "Just because you have some nefarious products coming in, doesn't mean you prevent people from getting access to appropriate, low cost drugs," a committee spokesperson said. According to Rep. Tom Coburn (R-Okla.), one of the House bill's sponsors, "We have a crisis in prescription drugs ... it is a crisis in price." Dingell argued, however, that the proposal could result in a flood of impure or imitation pharmaceuticals because the FDA cannot effectively police the way foreign companies produce, store and transport drugs. In a recent letter to the FDA, he wrote, "[T]he evidence suggests the problem is getting worse. ... [I]n our haste to find a way to bring cheaper drugs to seniors and other needy Americans ... we risk making changes to key health and safety laws we may later regret." To address safety concerns, Senate Health, Education, Labor and Pensions Committee Chair Jim Jeffords (R-Vt.) included safeguards to protect consumers from impure or imitation drugs in his version of the bill, which sailed through the Senate Wednesday. Dingell commended Jeffords on the Senate bill, calling it a "vast improvement" over the House version, but he still remains concerned about rescinding the import ban (Fulton, 7/21).

Beleaguered Drug Industry Hit Again
      Meanwhile, increased public awareness about drug pricing practices has created a "major political headache" for the embattled pharmaceutical industry, which spends millions of dollars each year on lobbying, advertising and campaign contributions. "The pharmaceutical industry has its teeth in both political parties. But there's such widespread support [for drug pricing legislation] that more and more politicians can stand up and tell these guys to go to hell," Rep. Bernie Sanders (I-Vt.), one of the sponsors of the House-passed drug import bill, said. And even if drugmakers can defuse the recent drug import legislation passed by both chambers of Congress, international price disparities will likely remain in the political spotlight. Although pharmaceutical officials concede that disparities exist, they blame much of the problem on price controls imposed by foreign governments. "Drug pric[ing] issues are very complicated, and it isn't possible to explain them in a soundbite ... this is a challenging time," Pharmaceutical Research and Manufacturers of America President Alan Holmer said. By paying more for drugs, U.S. consumers contribute disproportionately to the research and development of new drug, but they also receive additional benefits, such as faster access to new medicines, industry officials argue. In addition, generic and over-the-counter drugs often cost less in the United States, Patricia Danzon, professor of health care management at the University of Pennsylvania's Wharton School, said. On Aug. 8 and 9, the Clinton administration plans to hold a conference about drug pricing and cost-containment strategies, but industry officials fear the meeting could become a "forum for industry bashing" (McGinley/Zimmerman, Wall Street Journal, 7/21).