Pharma cheers health-reform legislation

After months of increasingly rancorous debate, the House finally approved legislation March 21 that makes significant changes in the nation's healthcare system. Among provisions sought by pharmacy interests, it includes a grants program for medication therapy management. The Senate is slated to approve the House-passed changes to its original reform bill shortly.

Most important to pharmaceutical companies, the legislation promises to significantly expand the number of Americans with some kind of healthcare coverage. This will enlarge the market for prescription drugs and moderate pressures for price controls. The legislation sets up a scheme to eliminate the confusing "doughnut hole" in the Medicare program, while avoiding proposals for government negotiation of Medicare drug prices. Drug reimportation is off the table, at least for the moment.

A major plus for the pharmaceutical industry is that the bill establishes a clear pathway for authorizing follow-on biologics. Brand-name firms won a 12-year period of data exclusivity, despite protests from generics makers. But all manufacturers are likely to benefit from clearer policies on how to proceed in developing and regulating "biosimilars" and "biobetters."

The legislation reshapes the health-insurance market as well as government healthcare programs, all promising to affect the coverage and delivery of prescription drugs. Implementation will be a huge challenge, especially for state governments. Republicans, as well as various interest groups, are already looking for revisions and challenges.