March 27, 2012 ·
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Industry Insights from Kristen Smithwick
Albeit a bit late, the U. S. Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on the Patient Protection & Affordable Care Act’s Physician Payments Sunshine Provision (also known as the “Sunshine Act”) to implement it as law.
CMS invited comments on the proposed rule through mid-February 2012, and a recent webcast, sponsored by PharmaLive’s Pharmalot, featured key facts and summaries of comments on the proposed rule. Working for a provider of research and consulting to the biopharmaceutical, medical device, and diagnostics industries on relationships with physicians and other health care providers, I enjoyed the opportunity to join the webcast, led by experts from Buchanan Ingersoll & Rooney, P.C., and am eager to share some of my key takeaways.
As mentioned in previous Thought Leader Select Blog posts, the Sunshine Act, as with many laws and regulations, is full of unintended consequences – some positive and some negative. Lance K. Stell, medical ethics teacher at Davidson College and Carolinas Medical Center, reports in his USA Today op-ed piece that the “Sunshine Act will cost far more than the $224 million estimated for just the first year of compliance” and that “the biggest cost will be the valuable, socially useful physician-industry collaborations that simply won’t occur.” Of course, the idea of ... read more »
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April 1, 2010 ·
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FOR IMMEDIATE RELEASE
April 1, 2010 (CHAPEL HILL, NC)—Paul Meade, President of Thought Leader Select, a North Carolina firm dedicated to better engagement and more sophisticated deployment of key opinion leaders for the pharmaceutical industry, issued the following statement regarding the Pharmaceutical Research and Manufacturing Association of America’s (PhRMA) March 21 statement on healthcare reform.
“I would like to echo PhRMA’s statement and say that the time has come to begin the long process of removing the existing barriers to care in the United States. With all the work that’s been done, both in Washington and at the companies who make up the biopharmaceutical industry, I applaud their collective efforts to bring real reform that offers healthcare to more than 32 million Americans. In addition, I hope we can begin to address some of the healthcare disparities that exist among the uninsured and the underinsured citizens of this country.
In this country, we are fortunate to have some of the world’s finest physicians and medical facilities, as well as a pharmaceutical industry that works very hard to bring the best treatments to market. I, too, believe that all Americans should have access to high-quality, affordable healthcare coverage and services. As long as we keep this goal in mind, along with continuously improving our levels of care and treatment, we can all work together ... read more »
TAGS: biotechnology healthcare reform patients Paul Meade pharmaceutical PhRMA physicians Thought Leader Select
March 2, 2010 ·
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KOLs Provide the “Voice of the Patient” for Life-changing Discoveries
According to the Pharmaceutical Research and Manufacturers of America (PhRMA—(http://www.phrma.org/), “Only one of every 10,000 potential medicines investigated by America’s research-based pharmaceutical companies makes it through the research and development pipeline and is approved for patient use by the United States Food and Drug Administration.”
Development of innovative medicines for effective disease treatment requires that pharmaceutical companies have a keen understanding of the diseases impacting patients and a view into how doctors see these medicines work in their patient populations. Without advice from physicians and scientists in the field, pharma companies may target the “wrong” illnesses or miss or miss opportunities to tackle the most complex diseases.
Physicians become the “voice of the patient” during the drug discovery and development process. Patients around the globe have the partnership of physicians, scientists and pharmaceutical manufactures to thank for longer life expectancy and the eradication of deadly diseases.
The most beneficial physician/scientist/pharma collaborations exemplify the following key hallmarks:
· Common goals for identifying patient needs, gaps in available treatments and potential new therapies
· Open exchange of patient needs and treatment ideas
· Critical, unbiased ... read more » TAGS: discovery drug development FDA innovation key opinion leaders patients pharma PhRMA
