President’s Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements
By Donald Zuhn –
Last week, President Obama unveiled his 2013 budget, and at least with respect to aspects of the budget proposal that would impact drugmakers, the President’s 2013 proposal looks a lot like his 2012 proposal. In a section of the budget proposal entitled “Health Savings,” the Administration sets forth eighteen proposals, the final two of which concern pay-for-delay agreements and the biosimilar regulatory pathway. With respect to pay-for-delay agreements, the budget seeks to:
Prohibit “Pay for Delay” Agreements to Increase the Availability of Generic Drugs and Biologics. The high cost of prescription drugs places a significant burden on Americans today, causing many to skip doses, split pills, or forgo needed medications altogether. The Administration proposes to increase the availability of generic drugs and biologics by authorizing the Federal Trade Commission to stop companies from entering into anti-competitive deals, known also as “pay for delay” agreements, intended to block consumer access to safe and effective generics. Such deals can cost consumers billions of dollars because generic drugs are typically priced significantly less than their branded counterparts. These agreements reduce competition and raise the cost of care for patients both directly, through higher drug and biologic prices, and indirectly through higher health care premiums. The Administration’s proposal facilitates greater access to lower-cost generics and will generate $11 billion over 10 years in savings to Federal health programs including Medicare and Medicaid.
As for biosimilars, the budget proposes to:
Modify the Length