The San Francisco Chronicle (7/15, E1, Tansey) reported that "[b]ig pharmaceutical companies with popular brand-name drugs have long faced competition from cheaper generic versions of those medicines. Soon, biotechnology companies -- until now exempt from generic competition -- could have the same headache. Congress is close to creating a way to approve discount copies of biotech drugs, a momentous move that would shake the biotechnology business to its roots. The off-price drugs could steal customers and drain revenue from established biotech companies, creating a much more challenging environment." Biotech drugs are the fastest-growing segment of the pharmaceutical market. "Biotech companies have been shielded from generic competition so far because the Food and Drug Administration has no procedure to approve copies of biotech medicines. These drugs, unlike simple pills such as aspirin, are often complex biological molecules produced by living cells rather than synthesized from chemicals. Ensuring that a knockoff has the same physical properties as the original biological drug can be a significant technical challenge." The debate now focuses on a Senate bill, The Biologics Price Competition and Innovation Act of 2007, "a bipartisan compromise crafted by Democrats Edward Kennedy of Massachusetts and Hillary Clinton of New York and Republicans Orrin Hatch of Utah and Michael Enzi of Wyoming. The bill has drawn praise and objections from both sides."
Dispute is over safety, length of patent protection. The San Diego Union-Tribune (7/13, Somers) noted that a major issue under debate is the length of time between when a biotech company introduces a drug and when a generic copy may be made available. "The industry says it needs 14 years of exclusivity to recoup its investment." Meanwhile, consumer groups "want five years of exclusivity. 'Each year of exclusivity will cost billions of dollars for the consumers, unions, employers and government agencies,'" one critic argued.
(Source: Health Law Daily, July 16, 2007)
