Urges Senate HELP Committee to Include ‘Real’  Biogenerics Legislation as Part of Health Reform

(Washington, DC)- The Pharmaceutical Care Management Association (PCMA) today launched a new ad campaign urging members of the U.S. Senate Health, Education, Labor, and Pensions (HELP) committee to include meaningful biogenerics legislation as a means to improve and finance broader health reform efforts.  PCMA President and CEO Mark Merritt issued the following statement:

“If this week’s report is accurate that Washington and the drug company lobby have reached some kind of new health reform ‘agreement,’ we sincerely hope that biogenerics is not part of it.  The drug lobby will truly have reason to celebrate if Washington either ignores biogenerics reform or, worse, establishes a new process that could actually forbid competition for years after patents expire.  

“Either outcome would mean sky-rocketing costs for seniors in the donut hole, taxpayers, employers, and patients who desperately need access to these expensive, life-saving medications.”

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Real Biogenerics Reform Will Save Billions, Help Finance Broader Health Reform

(Washington DC)-Both President Obama and The Medicare Payment Advisory Commission (MedPAC) today called for creating a pathway for the Food and Drug Administration (FDA) to approve follow-on biologics (FOBs), adding strong momentum to pass meaningful biogenerics legislation this Congress, according to the Pharmaceutical Care Management Association (PCMA).

"We need to introduce generic biologics into the marketplace," said President Obama in a speech to the American Medical Association today on health reform. The President emphasized that creating an FDA pathway for generic biologics "will save us billions of dollars."

Separately, the independent Congressional agency MedPAC said today that the "establishment of a regulatory approval process for FOBs is necessary to provide more competition among biologics and generate cost savings." Highlighting the issue’s importance, MedPAC included an entire chapter on follow-on biologics in its June report to Congress, "Improving Incentives in the Medicare Program."

"Real biogenerics reform will save billions that can be used to finance broader health reform," said PCMA President and CEO Mark Merritt.

Building on today’s news, a report released last week from the Federal Trade Commission (FTC)  found 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.

Introduced in the House of Representatives by Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO), "The Promoting Innovation and Access to Life-Saving Medicine Act " (HR 1427) would create a regulatory pathway for the FDA to approve generic versions of biologic products.  Companion legislation was introduced in the US Senate (S 726) by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), David Vitter (R-LA), Debbie Stabenow (D-MI),  Jeanne Shaheen (D-NH), and Mel Martinez (R-FL).

HR 1427/S 726 would give brand-name biologics five years of exclusivity before generic versions could enter the market and would allow for greater savings to fund broader health reforms, in contrast to the competing House bill (HR 1548), which would give brand-name biologic manufacturers up to an unprecedented 14 years of exclusivity before generic versions could hit the market.

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(Washington, DC)- The Pharmaceutical Care Management Association (PCMA) released the following statement today on the Administration’s comments regarding financing health care reform:

“PCMA shares the Administration’s passion for reducing costs, including for prescription drugs in Medicare.  The Administration and Congress took a major step in this direction with the recent “American Recovery and Reinvestment Act” (ARRA) which offers dynamic new HIT incentives that will propel physician adoption of e-prescribing to almost full adoption within the next decade.

“For our part, pharmacy benefit managers (PBMs) have reduced Medicare Part D costs by 30 percent below government projections by encouraging more generic utilization, using more affordable delivery vehicles such as home delivery, negotiating competitive discounts with retail pharmacies, and using tools like e-prescribing to cut waste and inform doctors and patients when safer, more affordable options are available.

“As the Administration seeks specific ways to address its cost-cutting goals, there are several policies that can accomplish this without restricting access to medications or shifting costs onto those who already enjoy drug benefits in private sector plan.  These include:

• Biogenerics Reform: Support bipartisan legislation sponsored by Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and others to create a regulatory pathway allowing the FDA to approve competing, generic versions of expensive biotech drugs;
• Eliminate so-called ‘protected drug classes’ in Medicare. These eliminate price competition among manufacturers of ‘me-too’ drugs without providing seniors greater access to those drugs. This reform alone would save $4.2 billion over 10 years, according to CMS;
• Increase efficiency and save billions by allowing greater use in Medicare of home delivery for re-fills of long-term, chronic medications; and
• Reduce waste by making formularies in Medicare Part D more resemble those in the Federal Employees Health Benefits Program (FEHBP), which is used for Members of Congress and other federal officials.”

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(Washington, DC)- A new report released today from the Federal Trade Commission (FTC) entitled “Follow-on Biologic Drug Competition” finds 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, the Pharmaceutical Care Management Association (PCMA) said today.

“This new report is good news and confirms that biotech products don’t need additional exclusivity protections before a generic competitor can enter the market,” said PCMA President and CEO Mark Merritt.  “The findings support Chairman Waxman’s approach to the issue and undermine other proposals which demand excessively long periods of exclusivity.”

Specifically, the report noted:

“Central to each of these exclusivities is a public policy trade-off: a restriction on competition is provided in return for the development of a new drug product or new use of an existing product. A 12- to 14-year exclusivity period departs sharply from this basic trade-off, because it does not spur the creation of a new biologic drug or indication. The drug has already been incentivized through patent protection and market-based pricing.

“The potential harm posed by such a period is that firms will direct scarce R&D dollars toward developing low-risk clinical and safety data for drug products with proven mechanisms of action rather than toward new inventions to address unmet medical needs. Thus, a new 12- to 14-year exclusivity period imperils the efficiency benefits of a FOB approval process in the first place, and it risks over-investment in well-tilled areas.”

Introduced in the House of Representatives by Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO), “The Promoting Innovation and Access to Life-Saving Medicine Act” (HR 1427) would create a regulatory pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products.  Companion legislation was introduced in the US Senate (S 726) by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), David Vitter (R-LA), Debbie Stabenow (D-MI),  Jeanne Shaheen (D-NH), and Mel Martinez (R-FL). 

HR 1427/S 726 would give brand-name biologics five years of exclusivity before generic versions could enter the market and would allow for greater savings to fund broader health reforms, in contrast to the competing House bill (HR 1548), which would give brand-name biologic manufacturers up to an unprecedented 14 years of exclusivity before generic versions could hit the market.  

“Many underestimated the savings from generics when the original Hatch-Waxman bill was passed into law,” Merritt added.  “Now, many underestimate the ability of generic biologics to save money. However, pharmacy benefit managers and others have consistently found new and innovative ways to promote generic utilization and competition.”

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(Washington, DC)-The Pharmaceutical Care Management Association (PCMA) issued the following statement in response to new comparative effectiveness legislation (“The Patient-Centered Outcomes Research Act of 2009”) introduced today by Senate Finance Committee Chair Max Baucus (D-Mont.) and Senate Budget Committee Chair Kent Conrad (D-N.D.):

“Comparative effectiveness research will improve clinical decision-making, enhance quality and discourage wasteful spending. 

“Pharmacy benefit managers (PBMs) have long been at the forefront of efforts to bring more measurement, accountability, and real-time information to the health care system.  Along with pharmacy & therapeutics (P&T) committees, other proven PBM utilization tools-including multi-tier formularies and step therapy-ensure that patients have access to cost-effective and clinically proven prescription drugs.”

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(Washington, DC)-The Pharmaceutical Care Management Association (PCMA) released the following statement today on a new Government Accountability Office (GAO) report on the Federal Employees Health Benefits Program (FEHBP) and enrollee cost sharing for selected specialty prescription drugs:

“The high prices of biotech drugs in the new GAO report underscore the importance of creating much-needed competition to lower costs and increase access for these life-saving products.  

“Despite these high prices, payers have worked hard to provide affordable benefits.  In the FEHBP program, the GAO report finds that nearly 9 out of 10 federal employees are in plans that limit out-of-pocket costs to about $55 per prescription, even for biotech medicines where annual treatment costs can exceed $25,000.

“Many of the high-cost biotech medicines examined by GAO do not face generic competition, straining public and private payers’ ability to provide affordable drug benefits for these necessary and often life-changing products.  Generic competition lowers costs because it gives patients the power to choose and gives manufacturers an incentive to reduce prices. 

“Meaningful biogenerics legislation should be the first stop for policymakers tasked with financing health reform. PCMA and a broad coalition of consumers, employers, labor unions, and others support bipartisan legislation which would create a regulatory pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products.”

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