BOOSTING GENERICS
GLENN HESS · Chemical & Engineering News · 2007
IN A BID TO LOWER health care costs for consumers and insurers, Congress is pushing legislation to expand and speed up the availability of generic drugs, including less expensive versions of boutique biotechnology-based medicines used to treat heart disease and other serious conditions. Bills introduced in the House and Senate on Feb. 14 would empower the Food & Drug Administration to approve generic counterparts to biotech drugs without requiring the generics manufacturers to repeat all of the costly and time-consuming clinical trials conducted by brand-name manufacturers. A separate measure approved by the Senate Judiciary Committee on Feb. 15, the Preserve Access to Affordable Generics Act (S. 316), would bar brand-name pharmaceutical companies from the profit-preserving practice of paying generics manufacturers to delay the introduction of cheaper, equivalent products. The biotech drugs at the heart of this legislation are proteins, not small molecules characteristic of conventional drugs. These medicinal proteins are among the fastest growing ...