The bipartisan Patients’ Access to Treatments Act (H.R. 460), introduced by Rep. David McKinley (R-WV) and Rep. Lois Capps (D-CA), limits cost-sharing requirements applicable to medications in a specialty drug tier (typically Tier IV or higher) to the dollar amount applicable to drugs in a non-preferred brand drug tier (typically Tier III). It will enable patient access to treatments, reduce disability and constrain health care costs.
The legislation will establish a national data surveillance system that will track and collect data on the epidemiology, incidence, prevalence, and other factors of neurological diseases, including Parkinson’s and Multiple Sclerosis (MS). The surveillance system will be developed and maintained by the Centers for Disease Control and Prevention (CDC). This system will provide researchers and epidemiologists with a coordinated system of health data on neurological diseases and should fuel further research.
New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations
By Kurt R. Karst, FDA Law Blog
Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.
Statement on Introducing the Compassionate Freedom of Choice Act, by Rep. Ron Paul (R-TX)
Mr. Speaker, I rise to introduce the “Compassionate Freedom of Choice Act.” This legislation allows terminally ill patients to use drugs, treatments and devices that have not yet been approved by the Food and Drug Administration (FDA) if their physicians certify: (i) such patients have no other treatment options; and (Ii) the patient executes written, informed consent that they are aware of any potential risks from the drug, device, or treatment.
Congressman Brian Bilbray introduces bill to provide patients fighting life threatening diseases greater access to treatment
Washington, D.C. – Congressman Brian Bilbray (CA-50) today introduced H.R. 6288, the Patient Choice Act of 2012, a bill to speed up the approval process of drugs used in therapies and treatments of patients fighting life threatening diseases.
One Hundred Twelfth Congress of the United States of America
An Act To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.
Signed into law on July, 9, 2012
Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourage the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.
Rare disease advocate says the focus should be on ensuring the accelerated approval expansion and surrogate endpoint guidances become FDA priorities as the rare disease drug program is set to grow under PDUFA V.
Regulatory Update / Article # 00120917013
Congress mandated specific upgrades to FDA’s rare disease program in the new user fee legislation, but the largest impact may come through the expected changes to the accelerated approval pathway.
BY ELIZABETH M. WROE & PHILIP S. BONFORTE
The threat of a delayed or deterred (re-)authorization of key Food and Drug Administration (FDA) user fee programs (hereinafter referred to as the ‘‘FDA user fees’’) caused significant angst among biomedical product stakeholders over the course of the last year and a half.