WASHINGTON - The bill Congress is soon expected to pass giving regulators more authority over pharmaceutical companies is most significant to biotech drug makers and their would-be generic rivals because of what was left out.
Generic drug makers such as Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals failed to persuade lawmakers to attach legislation that would allow them to market generic versions of biotech drugs produced by the likes of Amgen Inc. and Genentech Inc. US sales of biotech drugs grew nearly 20 percent last year to $40.3 billion, according IMS Health, a healthcare information company.
Fortunately for the Amgens and Genentechs of the world, it will likely be years before they face the same kind of market pressures as Pfizer Inc. and other makers of chemical-based drugs, who must compete with generic versions of their products after they lose patent protection.
The legislation, which passed the House on Wednesday and the Senate yesterday, gives the Food and Drug Administration more authority to scrutinize drugs after they reach the market, including power to mandate label changes that warn of new risks.
But the provision generic drug makers had hoped for would have given the FDA the legal authority to approve generic biotech drugs. Some analysts say that with no major healthcare bills expected to move through Congress in 2008, the generic drug lobby might not have a legislative vehicle to help realize its goals.
"Typically healthcare legislation does not pass as a stand-alone bill unless there is either enormous political pressure or political consensus," said Lehman Brothers analyst Tony Clapsis. "When you have conflicting views on an issue, as you do on follow-on biologics at this stage, it's very hard to get a stand-alone bill through Congress."
Generic Pharmaceutical Association president Kathleen Jaeger says her group raised the profile of the generic drug issue this year, pointing out organizations ranging from AARP to the PepsiCo Inc. have signed on to the effort to approve cheaper biotech medicines.
Ira Loss of Washington Analysis Corp. said he believes a compromise on generic biotech is almost inevitable in either 2008 or 2009. However, he noted there is still major disagreement between lawmakers in the House over when and how generic companies should be allowed to launch competing drugs.