Diverse Coalition of Purchasers Respond to BIO CEO Fly-In: There is Another Side to...( Patients Need A Biogenerics Path...)

Patients Need A Biogenerics Pathway that DOESN'T Keep Them Waiting

WASHINGTON, April 16 /PRNewswire-USNewswire/ -- With dozens of biotech and drug company CEOs flying to Capitol Hill to meet with members of Congress, The Coalition for a Competitive Pharmaceutical Market (CCPM) today released a new ad urging members to keep the best interests of patients in mind as they consider legislation to create a workable approval pathway for safe, effective and affordable biogeneric medicines.

The ad, "What If Patients Had Wings?," states that meaningful biogenerics legislation should ensure that patients have access to life saving biogeneric medicines sooner rather than later. Such legislation must strike the balance of fostering innovation without harming patient access through excessive and unprecedented market exclusivity which simply extends brand monopolies and stifles competition. A bill that does not achieve this objective will be an empty promise to patients.

A broad coalition of patients, seniors, consumers, businesses, labor, pharmacists, health plans, pharmacy benefit managers, and generics supplemented this effort by sending a letter to House Energy and Commerce Committee Chairman John Dingell and Ranking Member Joe Barton reiterating its principles for workable and balanced biogenerics legislation that:

1. Empowers the FDA to use its expertise to determine on a case by case

basis what scientific data they need to approve comparable and

interchangeable products.

2. Does not include administrative barriers that impede FDA's ability to

approve safe and effective biogenerics.

3. Provides a clear framework for interchangeability that is immediately

operative and does not require additional congressional action.

4. Ensures predictability for when scientifically-proven, safe and

effective biogenerics can enter the marketplace.

5. Provides a clear and
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