House Approves Four Bills Related to Prescription Drugs, Medical Devices

The House this week approved several bills related to prescription drugs and medical devices. Summaries appear below.

• Buprenorphine: The House on Wednesday unanimously approved a bill (S 45) that would end a federal restriction on the number of patients who can be prescribed buprenorphine -- an opiate substitute used to treat heroin or painkiller addictions -- at physician group practices, the Baltimore Sun reports. Buprenorphine has advantages over methadone in treating addiction (Baltimore Sun, 7/28). The bill would preserve the 30-patient limit for individual doctors (Schuler [1], CQ Today, 7/27). The Senate already has approved the bill, and President Bush is expected to sign it (Baltimore Sun, 7/27).
  


• Electronic records: The House on Wednesday by voice vote passed a bill (HR 1132) that would authorize grants to states to establish a uniform system for tracking prescriptions and maintaining electronic records as a way of preventing prescription drug abuse, CQ Today reports. The Senate Health, Education, Labor and Pensions Committee approved companion legislation (S 158) in May, and the full Senate is expected to pass the bill (Schuler [2], CQ Today, 7/27).
  


• Exportation: The House on Wednesday approved a bill (S 1395) that would revise the Controlled Substances Import and Export Act to allow pharmaceutical companies to ship Schedule I, II, III and IV drugs to a distribution point in one country and then ship them to other countries in the region, CQ Today reports (Schuler [3], CQ Today, 7/27). The bill would give the U.S. attorney general authority over the export of controlled substances (Loyd, Philadelphia Inquirer, 7/28).
  


• Medical Devices: The House on Tuesday approved a bill (HR 3423) that would amend a provision in the Medical Device User Fee and Modernization Act that would end user-fee requirements for medical device manufacturers if Congress fails to allocate a certain amount of funding for device reviews, CQ Today reports. Congress fell short of its funding obligations for device reviews in fiscal years 2003 and 2004. The user-fee program, which helps fund FDA reviews of devices and speed approval times, is scheduled to end Sept. 30 unless Congress takes action. The Senate is expected to approve the bill, possibly this week (Schuler, CQ Today, 7/26).