National Experts Call on Congress and White House to ‘Revisit’ Pending Bills That Grant Biologics an Unprecedented 12-Year Exclusivity Period

(Washington, DC)-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.  

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Consumer Reports Survey Finds Consumers Cutting Back on Care to Save Money

(Washington, DC)- Many consumers looking for ways to reduce their health care costs are taking potentially dangerous steps such as foregoing prescription drug medications altogether or skipping necessary refills, according to a new survey from Consumer Reports.  In tough economic times, the survey underscores the need for consumers to examine prescription drug cost-savings options such as the increased use of generic medicines and mail-service pharmacies, the Pharmaceutical Care Management Association (PCMA) said today.

“Greater use of mail-service pharmacies, generic medications, and a thorough medication review with a physician to determine other available prescription drug options are all avenues for consumers faced with difficult health care decisions and looking for ways to save,” said PCMA President and CEO Mark Merritt.  “This survey is also a reminder that any reforms in health care must address controlling costs for consumers and payers.  Creating a real pathway for biogenerics to increase competition for high cost biotech products along with providing greater incentives for mail-service pharmacies in public programs are common sense proposals which both lower costs and increase access.”

The Consumer Reports survey found that people have tried to cut back on health care costs in a variety of ways, including:

• 25 percent have been unable to afford medical care or medications.
• 20 percent skipped filling prescriptions.
• 15 percent took expired medication.
• 15 percent skipped scheduled dosages of prescriptions.

PCMA believes policymakers should explore prescription drug cost-savings options for consumers and payers in the health reform debate, including:

• Address the biotech cost-crisis through real biogenerics reform. Legislation creating a workable and meaningful biogeneric pathway is essential to curb the skyrocketing cost of biotech medicines. Like the White House, PCMA believes that offering seven additional years of ‘market exclusivity’ to the handful of companies who make biologics would be ‘generous.’
• Expand seniors’ mail-service pharmacy options. While numerous independent studies have documented that mail-service pharmacies reduce drug costs and provide greater safety and convenience, Medicare beneficiaries are not given the same incentives to use this proven delivery system as the under-65 population. Congress would help seniors – and taxpayers – save billions if health reform expands seniors’ access to chronic care medications delivered through mail-service pharmacies.
• Promote more competition in Medicare by requiring brand-name drugmakers to negotiate on all Part D drugs. Regrettably, Medicare Part D insulates drugmakers from competition by requiring drug plans to cover “all of substantially all” drugs in at least six different drug classes, despite no evidence that patients have had difficulty accessing these drugs. In doing so, this provision merely allows brand-name drugmakers to charge higher prices because they know plans are required to include their drugs on formularies, whether they offer discounts or not. According to CMS, removing this pharma-friendly requirement would save Medicare $4.2 billion over ten years.

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