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News and Press: Policy News

Federal Policy Advocacy Alert: June 6, 2014

Friday, June 6, 2014   (0 Comments)
Posted by: Stephen Rapundalo
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House Energy & Commerce Subcommittee To Review Incentives for Drug Development
The House Energy & Commerce Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), has scheduled a hearing for June 11, 2014, entitled "21st Century Cures: Examining the Role of Incentives in Advancing Treatments and Cures for Patients." To help advance the 21st Century Cures initiative, the Health Subcommittee continues its examination of the state of biomedical innovation by hearing from experts on whether additional incentives are necessary to accelerate the discovery, development, and delivery cycle. Members are keen to learn what gaps must be closed between the discovery and regulation of new cures and treatments, and how to spur the development of innovative new drugs and devices for patients with unmet medical needs.

FDA Issues Expedited Programs Final Guidance
On May 29, the FDA issued its final guidance on "Expedited Programs for Serious Conditions - Drugs and Biologics." This guidance provides a single resource for information on the FDA's policies and procedures related to the following expedited programs for serious conditions: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. The guidance describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. This guidance also discusses considerations for expedited development and review such as manufacturing and product quality, nonclinical studies, and clinical inspections. This guidance finalizes the draft guidance issued in June 2013.

The final guidance retains much of the contents of the draft version and reflects changes in the FDA's thinking about the breakthrough therapy program based on its review of approximately 186 requests for designation to date, 48 of which have been granted. The guidance also provides new details related to accelerated approval.

Key themes include explicit references to flexibility related to rare disease, the incorporation of the benefit-risk paradigm, and clearer statements that products "prevent[ing] a serious condition or reduc[ing] the likelihood that the condition will progress to a more serious condition or a more advanced stage of disease" should be eligible for these expedited programs.

Part D Final Rule Released - Centers for Medicare and Medicaid Services (CMS) Holds Off Key Changes
The CMS has put on hold key pieces of its proposed drug and Medicare Advantage proposed rule. A final regulation was released today in the Federal Register. The final rule does not rescind protected drug classes or limit the number of plans that insurance companies may offer, nor does it open preferred pharmacy networks.

The original proposed changes to regulations for Part D and Medicare Advantage plans were controversial on several fronts. The CMS received more than 7,500 comments and had to back off when the heat got too much.

However, the CMS is following through on the following changes and requirements:
  • Requires Part D prescribers to enroll in Medicare. "CMS is requiring that physicians and eligible professionals who prescribe covered Part D drugs be enrolled in Medicare, or have a valid record of opting out of Medicare, in order for their prescriptions to be covered under Part D. Requiring prescribers to enroll in Medicare would help CMS ensure that Part D drugs are only prescribed by qualified individuals," the rule states, adding that it allows extra time, until June 1, 2015, for that requirement to take effect.
  • The CMS, its antifraud contractors and other oversight agencies will have the ability to collect information directly from pharmacy benefit managers, pharmacies, and other entities that contract or subcontract with Part D sponsors to administer the Medicare prescription drug benefit. 
  • Revokes Medicare enrollment from physicians who abuse their prescribing rights.
  • Expands incentives for activities that promote improved health, efficient use of healthcare resources and prevent injuries and illness.
  • Allows the release of more privacy-protected Part D data. 
FDA Issues Guidance on Clinical Investigation Oversight
The FDA issued a guidance document entitled ''Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The guidance discusses the regulatory responsibilities of IRBs, clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. 

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