PhRMA Statement on Release of Sequestered FY2013 PDUFA Fees in Omnibus Spending Package

WASHINGTON, D.C. (January 14, 2014) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, PhD, issued the following statement on the release of sequestered prescription drug user fees included in the omnibus spending package filed yesterday:

Understanding Patient Perspective Critical in Benefit-Risk Assessment

01.06.14 | By

The assessment of the benefit-risk balance of a medicine is a key component of the drug development and regulatory review process. This assessment is also an important determination that each patient and doctor must make when choosing a treatment strategy.

Upholding Ethical Standards

12.28.13 | By

The best health stems from the best information, and this includes biopharmaceutical information-sharing with physicians and patients. As the creators of many of the medicines we all rely upon, the companies have the most up to date knowledge on safety and benefit/risk, making conversations with prescribing physicians imperative to better care.

TPP and Intellectual Property

12.20.13 | By

What provides two-thirds of the Trans-Pacific Partnership (TPP) agreement’s total economic benefits? The answer is intellectual property-intensive manufacturing industries.

Cost of Cancer Medicines

12.19.13 | By

Rather than trying to uncover what’s at play behind a woman’s struggle to pay for the costs of her leukemia medicine, last night’s ABC World News with Diane Sawyer barely scratched the surface of a complex issue. The result: a one-sided, overly simplistic view of the cost of cancer medicines in the United States.

A Conversation on Healthcare in 2013

12.17.13 | By

When we launched Conversations in June of this year, our goal was to blend formal contributors with an ongoing opportunity for experts and thought leaders to weigh in on a broad range of high-level policy topics. The forum has been a tremendous success. So far this year, we have seen 19 unique questions with over 90 responses from a variety of thought leaders and stakeholders, both inside and outside of the healthcare space.

Beyond the Label

12.17.13 | By

Last week, I had the opportunity to participate in a panel discussion at the Elsevier Business Intelligence FDA/CMS Summit entitled, “Beyond the Label.” 

Information Exchange

12.16.13 | By

PhRMA Pushes Back on New York Times

A Fully Collaborative and Informed Ecosystem

12.16.13 | By

Worth a read are the commentaries surrounding the latest Room for Debate question posed by the New York Times; it’s a good snapshot into the various views on the issue of biopharmaceutical and physician interaction. Our CEO, John Castellani, joined five other health care leaders in the discussion, sharing his perspective on how these interactions represent collaboration and not “influence” (as suggested in the original question).

Clinical Trials in Minnesota

12.13.13 | By

I walked away from Friday morning’s “Research in Your Backyard:  Pharmaceutical Clinical Trials in Minnesota” breakfast meeting in Minneapolis mightily impressed with two things: Frank Jaskulke’s very maroon and gold running shoes –a great contrast with the conservative suit the Minnesota life sciences thought leader was wearing – and what I learned about the work of the 


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