New England Journal Of Medicine Article: Biogenerics Legislation Should Grant 5 Years Exclusivity

Main Category: Pharmacy / Pharmacist
Article Date: 16 Oct 2009 - 19:00 PDT

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In a new article published in the New England Journal of Medicine (NEJM), a patent expert and Harvard researchers urge Congress and the White House to "revisit" pending biogenerics legislation that would grant biotech companies an "iron clad 12-year exclusivity period" for expensive biologics instead of the long-standing 5-years of monopoly pricing granted to brand-name chemical drugs. The experts add their voice to an emerging consensus, including the Federal Trade Commission, which has concluded that 12 years of market exclusivity for biologics is unnecessary, the Pharmaceutical Care Management Association (PCMA) said today.

"Biogenerics reform should be the 'low-hanging fruit' of cost-containment in health reform," said PCMA President and CEO Mark Merritt. "Consumers, employers, and taxpayers would save hundreds of billions in health spending if expensive biotech drugs faced the same generic competition as traditional brand-name drugs. Giving biologics 12 years of monopoly pricing power is costly and unreasonable."

The NEJM article specifically notes that:

"….as currently fashioned, the biosimilar legislation would have no value, because it would create a pathway that would scarcely be used. Innovators would not get the benefit of the exclusivity provision, and the public would not get the benefit of the enhanced price competition that would result from increasing the number of competitors."

In addition to the NEJM article, government agencies, respected thought-leaders, and the Administration have all weighed in that 12 years of exclusivity is excessive.

- The Federal Trade Commission (FTC) concluded in a major report earlier this year that patents for biologic products already provide enough incentives for innovation and that additional periods of exclusivity would "not spur the creation of a new biologic drug or indication" and "imperils" the benefits of the approval process.

- In June, the White House sent a letter to Energy and Commerce Committee Chairman Henry Waxman which stated that seven years of exclusivity is a "generous compromise between what the FTC research has concluded and what the pharmaceutical industry has advocated."

- Former U.S. House Ways and Means Committee Chairman Bill Thomas stated this week that 12 years of exclusivity for innovator biologics is "outrageous" and that policymakers should work to lower the number during any conference committee negotiations.

Source
Pharmaceutical Care Management Association