White House Deficit Reduction Plan Targets Biologic Exclusivity Period - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

White House Deficit Reduction Plan Targets Biologic Exclusivity Period

ePT--the Electronic Newsletter of Pharmaceutical Technology

President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted. The first is a proposal to reduce the period of exclusivity for biologics from the current 12 years to seven years. In addition, the practice of evergreening—extending the exclusivity period by making minor changes in product formulation—would be prohibited. According to the report, “The Administration’s proposal strikes a balance between promoting affordable access to medications and encouraging innovation to develop needed therapies. The proposal will result in $3.5 billion in savings over 10 years to federal health programs including Medicare and Medicaid.”

Another provision would give the Federal Trade Commission the authority to prohibit pay-for-delay agreements, in which a manufacturer of an innovator product pays to delay the entry of a generic drug onto the market. The proposal is intended to increase patient access to generic drugs and biologics, and the administration projects that the policy would save federal health programs $2.7 billion over 10 years.

Also included in the plan is a proposal to align Medicare drug-payment policies with Medicaid policies for low-income beneficiaries. The plan would require the same drug rebates that are offered to Medicaid recipients to be offered under Medicare Part D. It is estimated that the policy change would result in $135 billion in savings over 10 years.

See related Pharm Tech articles:

FTC Finds 60% Increase in Pay-to-Delay Deals (ePT)

Health-Reform Controversies (Pharmaceutical Technology)

PhRMA Opposes Changes to Medicare Part D (ePT)


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here