Prescription Drug User Fee Rate Exceeds $2 Million per Application

08.06.13 | By

Last week, the U.S. Food and Drug Administration (FDA) announced the prescription drug user fee rates for FY2014 –$2.169 million per application requiring clinical data review.  This reflects a significant increase of more than 10 percent over the FY2013 rates – and a twenty-fold increase in the user fees established in the Prescription Drug User Fee Act (PDUFA) of 1992.

Request for Comments on Docket No. FDA-2013-N-0556

July 30, 2013

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. FDA-2013-N-0556 – New Approaches to Antibacterial Drug Development; Request for Comments, 78 Fed. Reg. 105, 32669 (May 31, 2013)

Dear Sir or Madam:

Encouraging FDA to Utilize Existing Regulatory Flexibility to Facilitate the Development and Approval of New Antibacterials

08.05.13 | By

As noted in past Catalyst posts, the urgent need for new antibacterials is undisputed.  A recent article in Nature states that, “Health officials are watching in horror as bacteria become resistant to powerful carbapenem antibiotics — one of the last drugs on the shelf.”

MS Can’t Take Away Hope

08.02.13 | By

We recently released our Medicines in Development for Neurological Disorders report, which includes 38 medicines for multiple sclerosis (MS). It is a condition that impacts approximately 500,000 Americans. We recently had an opportunity to speak with Jodi Dwyer, a health activist who has MS and hope for a cure.

MS Can’t Take Away Hope

Industry Support for Exempting FDA User Fees from Sequestration

Washington, DC – August 1, 2013 – Today, Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt, (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration.  A similar bill, H.R. 2725, was introduced in the U.S.

Statement on Physician Payments Sunshine Act

WASHINGTON, D.C. (July 31, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Matthew Bennett issued the following statement today:

“PhRMA is committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information.

Great news for Part D beneficiaries as it nears its 10 year anniversary

08.01.13 | By

As we approach the 10 year anniversary of Part D being signed into law, more good news recently came out of CMS about the program. Their data showed that average monthly premiums are projected to stay stable at $31 for the 2014 plan year. Additionally, the Part D deductible will decrease from $325 to $310 next year – creating more savings for beneficiaries.

New Survey Identifies America’s Health Priorities: Obesity, Cancer Cures, Senior Care

WASHINGTON, D.C. (August 2, 2013) – A new survey commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows 86 percent of Americans believe developing cures for more forms of cancer should be one of the top national health priorities, followed by developing effective treatments for heart disease (78 percent) and more intensive medical care for seniors (76 percent).

PhRMA's First Annual Survey

08.01.13 | By

How long do you think you’ll live? Do you feel like you had a pretty good health year thus far? What about your neighbors and those in your community – how’s their year been, health-wise? What cures do you think will be discovered next in medicine?

The Need to Address Diseases and Disorders of the Brain

07.31.13 | By

The human brain, despite weighing just 3 pounds, contains over 100 billion neurons -- to say that it's complex is an understatement. These neurons are responsible for receiving messages and forwarding them to the appropriate parts of the brain, which in turn control everything we do. Considering the millions of tiny actions that make up just one day of your life, we may underappreciate just how much the brain can do for a person until something happens to it.

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