The Catalyst

PDUFA 101

Posted by Andrew Powaleny on September 3, 2015 at 9:00 AM

With Prescription Drug User Fee Act (PDUFA) VI FDA-Industry negotiations about to commence, we’re taking a look at what PDUFA is, how it works, and explaining why it has been a tremendous success for patients. PhRMA and the Biotechnology Industry Organization (BIO) will partner in negotiations, alongside consumer advocacy groups, health care professionals and scientific and academic experts. The U.S. Food and Drug Administration (FDA) initiated the PDUFA reauthorization process through a public meeting on July 15, 2015.

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Topics: FDA, R&D, HIV/AIDS, PDUFA

5 Things You Didn’t Know about Researching and Developing a New Medicine

Posted by Emma Van Hook on September 2, 2015 at 9:00 AM

Unless you work in biopharmaceutical research and development (R&D), chances are the process of developing new medicines seems like a black box. It is hard to imagine how researchers go from an initial idea, based on the underlying biology of a disease, to the development of a safe and effective treatment, and the many complex challenges researchers face in getting there.

PhRMA has released a new resource, “Biopharmaceutical Research & Development: The Process Behind New Medicines,” which explains the complexities inherent in developing a new medicine for patients. Our increasing understanding of the underlying biology of many diseases creates tremendous opportunity for the development of innovative new medicines.

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Topics: Innovation, R&D, Clinical Trials

340B Mega Guidance

Posted by Allyson Funk on September 1, 2015 at 1:53 PM

PhRMA appreciates the Health Resources and Services Administration’s (HRSA) efforts in releasing the 340B mega guidance and is pleased to have an opportunity to comment before the guidance is finalized.

A first look at the guidance indicates both positive signs that HRSA is taking steps to curb abuses of the program as well as some causes for concern.

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Topics: 340B, GAO, HRSA, hospitals

#pass4prostate: Tackling Prostate Cancer through Awareness, Research

Posted by Guest Contributor on September 1, 2015 at 9:00 AM

 

Considering that 1 in 7 men will be diagnosed with prostate cancer at some point in their lives, I suspect nearly everyone reading this column has been touched by the disease – whether as a patient, family member, friend or colleague.

According to the Prostate Cancer Foundation, approximately 220,000 American men will be diagnosed with prostate cancer this year and over 30,000 will die.

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Topics: cancer, member companies, Patients, patient advocacy

Medicare Monday: What does Medicare Part B Cover?

Posted by Allyson Funk on August 31, 2015 at 9:00 AM

You’ve probably heard the Medicare alphabet before: Part A, Part B, Part D and more. But what does all of it mean? We talk a lot about the Medicare Part D prescription drug benefit here on Medicare Monday, but what about the rest of the Medicare alphabet? Today, we’re tackling Medicare Part B and what it covers.

First, Medicare Part B is commonly referred to as the Medicare medical benefit and covers a wide range of health care services. Medicare Part B covers physician office visits, outpatient care, ambulance services and medical equipment like a wheelchair or walker. To learn more about what Medicare covers, check out Medicare.gov.

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Topics: Part D, Medicare, Medicare Monday

10 Years Later: Lessons Learned from Hurricane Katrina

Posted by Allyson Funk on August 28, 2015 at 2:50 PM

Ten years ago today I was lucky to have evacuated from New Orleans to Atlanta and sat waiting to see what would happen with the storm of the century. Having evacuated countless times before, I could only hope this would be another false alarm. But waking up to see my city under siege and the devastation wrought by the storm across the Gulf Coast, everyone knew this was only the beginning. The road to recovery would be a long one.

Hurricane Katrina taught us, taught America, a lot of lessons. One of those lessons was about preparedness and the need for coordinated help when disaster strikes.

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Topics: Natural Disaster

Week in Review: The Latest from PhRMA

Posted by Priscilla VanderVeer on August 28, 2015 at 12:00 PM

Developing New Medicines:  Innovative medicines offer hope to patients and bring value to the health care system, but developing these new treatments is a rigorous, lengthy and costly process, and more obstacles may be on the horizon.

  • Take a look at our new video and infographic to learn more about why developing a new drug is harder than rocket science.
  • There’s a lot that can be missed when you take a very limited look at the FDA’s drug approval process. Read more about the parts that weren’t addressed in a recent Forbes’ story. 
  • Learn more about the surprising supporters of state proposals to enact price controls and why those efforts could further inhibit progress towards innovative treatments and cures.

Free Trade Agreements May Be Good For Your Health:  A new report by the Geneva Network titled “Trading for Health: Quantifying the Impact of Free Trade Agreements on Health Outcomes” demonstrates that trade openness and Free Trade Agreements (FTAs) yield overall positive health outcomes and socio-economic benefits. Learn more here.

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Topics: diabetes, Week in Review, trade, Forbes

Free Trade Agreements May Be Good For Your Health

Posted by Mark Grayson on August 27, 2015 at 3:00 PM

A new report by the Geneva Network titled “Trading for Health: Quantifying the Impact of Free Trade Agreements on Health Outcomes” recently called into question many claims being made by groups opposing the Trans-Pacific Partnership (TPP). Among the report’s most interesting conclusions, the authors found that trade openness and Free Trade Agreements (FTAs) actually improved health outcomes.

In particular, the study notes that several FTAs in the last 15 years contain intellectual property (IP) provisions for innovative biopharmaceuticals that are more robust than the minimums established in the TRIPS agreement, and disproved claims that stronger IP protections have undermined access to medicines.

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Topics: IP, TPP, trade

Ask About Adherence: Q&A with The Peter Lamy Center for Drug Therapy and Aging

Posted by Samantha Dougherty on August 27, 2015 at 12:00 PM

Ask About Adherence is a blog series featuring Q&A’s with experts in medication adherence. In this post, we speak with Bruce Stuart, PhD, executive director of the Peter Lamy Center for Drug Therapy and Aging and professor in pharmaceutical health services research about his recently published article “Does good medication adherence really save payers money?” Dr. Stuart set out to determine to what degree medicines reduce medical spending by comparing Medicare spending among Part D enrollees with diabetes who were adherent to their medications to those who were not. His analysis found that there is a substantial benefit even when taking the healthy adherer effect into consideration – up to $6400 a year per person.

Stay tuned for the next Q&A and be sure to share your thoughts in the comments section below. We’d love to hear from you on ways to improve medication adherence!

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Topics: adherence, Part D, Medicare, #Adherence123s, Ask About Adherence

Burden on Patients: 5 Questions on Access to Diabetes Medicines in Health Exchange Plans

Posted by Allyson Funk on August 27, 2015 at 9:00 AM

Patients, especially those suffering from chronic conditions, deserve access to the medicines they need to live longer, healthier lives. Today, PhRMA released a new fact sheet on access to diabetes medicines in exchange plans in 2015 (2014 fact sheet is available here). The fact sheet highlights some of the potential barriers to accessing needed treatments. Learn more on AccessBetterCoverage.org, in our patient profiles and our other fact sheets.

This is the fifth post in our Burden on Patients Q&A series with patient advocates. To learn more, we talked with Larry Hausner, longtime patient advocate, former CEO of the American Diabetes Association and chief patient advocate for the Partnership to Fight Chronic Disease.


Question (Allyson Funk): Can you tell me about you, your career representing patients and what you’ve learned over the years representing patients with diabetes?

Answer (Larry Hausner): I worked, as the CEO of the American Diabetes Association (ADA) for seven years and during that time the most important thing to me was to make sure that the needs of diabetes patients were represented in what we were doing. We tried to do everything we could to better the quality of life for those with the disease. That includes Type 1 and Type 2 patients as well as those with gestational diabetes. Over time we wanted to make sure when you looked at any aspect of a person with diabetes’ life that the American Diabetes Association was there to help.

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Topics: Access, diabetes, ACA, exchanges, Access Better Coverage, ABCs of Coverage

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