Archive for the ‘Congress’ Category

Amanda
Sellers

PDUFA: The Cliffs Notes

Thursday, May 17th, 2012

There has been a lot of buzz lately about Congress’ reauthorization of the Prescription Drug User Fee Act, affectionately known as PDUFA (pronounced: pah-du-fa) inside the beltway and in the halls of pharmaceutical and biotech companies. Traditionally, PDUFA is an issue that only D.C. health policy wonks get excited about, as it goes in front of Congress about every five years. But times have changed, especially with the United States public so tuned into health care these days. The once little-known PDUFA reauthorization has been the talk of the health care town and is getting more press nationwide than it has in years past, covered most recently in Forbes by Doug Schoen and in the Washington Post as the “most important health policy you’ve never heard of.” Even patient advocates like NORD are getting in on the PDUFA hype to champion the part of legislation that supports drugs for rare diseases.

I think it’s about time.

For those who are not familiar with PDUFA, here’s a Cliff Notes version as to what it is, why it matters and, most importantly, what it means for patients:

Definition of PDUFA: A law enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III) and 2007 (PDUFA IV), which authorizes FDA to collect fees from companies that produce certain human drug and biological products.

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Luke
Dickinson

Supreme Court Hears Arguments Over Health Care Reform – Wednesday Update

Thursday, March 29th, 2012

As the third and final day of the oral arguments over Health Care Reform in the Supreme Court closed, the uncertainty over the Court’s anticipated decision grows even stronger. Many believe that the law is in jeopardy over the constitutionality of the individual mandate, the provision requiring all Americans to purchase health insurance. And the third day of arguments made it clear that if the individual mandate fails, there is a strong likelihood that the entire ACA will fall with it.

Day three kicked off with arguments around the severability issue of whether the ACA can remain in action if individual elements of it are deemed unconstitutional, specifically the individual mandate provision. As oral arguments and questioning developed, it quickly became clear that the Court is stuck on their political divisions.

Liberal Justices who support the ACA argued that there are too many vital elements of the law to be thrown out if one element fails, while conservative Justices questioned how Congress can salvage the law if central elements are picked apart.

“Is half a loaf better than no loaf? And on something like the [health insurance marketplace] exchanges it seems to me a perfect example where half a loaf is better than no loaf. The exchanges will do something.” – Justice Elena Kagan

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Luke
Dickinson

Supreme Court Hears Arguments Over Health Care Reform -Tuesday Update

Wednesday, March 28th, 2012

(Dana Verkouteren/AP Photo)

As the dust settles on the second day of arguments in the Supreme Court over Health Care Reform legislation, there is an overwhelming sense by observers that the Patient Protection and Affordable Care Act (ACA) is in jeopardy of being struck down by the Supreme Court.

Conservative Justices heaped pressure on U.S. Solicitor General Don Verrilli – who is arguing in support of the Obama Administration’s landmark piece of legislation – picking apart the individual mandate, the requirement that under ACA all Americans purchase health insurance. Setting aside the issue of quality or access to care, Justices focused on the commerce issue of the mandate, examining whether the government is changing its relationship with the people in making them purchase a commercial product and what else that might lead to.

“Everyone subject to this regulation is in — or will be in — the health care market. They are just being regulated in advance. That’s exactly the kind of thing that ought to be left to the judgment of Congress and the democratically accountable branches of government.” – U.S. Solicitor General Don Verrilli

“So can the government require you to buy a cell phone because that would facilitate responding when you need emergency services?” – Chief Justice John Roberts

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Anthony
LaFauce

What does Google’s Fine Mean for Your PPC?

Wednesday, August 24th, 2011

Today or tomorrow the Department of Justice is expected to announce Google will have to pay half a billion dollars in fines for ads run on its network that sold illegal drugs.  For the better part of a year, Google had been battling with online  ’pharmacies’ about the products they sell.

Google had stated in official documents, due to the difficult nature of regulating ads on their network they shouldn’t be held accountable for ads they were actively removing.  Google’s official statement, “… it’s obvious with hindsight that we shouldn’t have allowed these ads on Google in the first place. Given the extensive coverage this settlement has already received, we won’t be commenting further,” is clear and concise. They messed up and they know it.

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Anthony
LaFauce

Can You Hear Me Now: FDA Still Not Talking

Friday, April 1st, 2011

Speak no evil

For the last few months everyone in the PR/marketing industry has been waiting for a few words from our friends at the FDA. I personally wrote about the FDA’s inability to come to terms with a social media policy back in December.

Last year the FDA made a clear statement to the world with this announcement: Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.”

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John
Seng

Terrible Tuesday?

Monday, November 1st, 2010

Will tomorrow’s mid-term elections spell doom for House Democrats and open the door to potential repeal of the Patient Protection and Affordable Care Act?

Marsha Simon, PhD, Health Policy Expert President, MJ Simon & Company

Marsha Simon, PhD, Health Policy Expert President, MJ Simon & Company

In the past two days, I decided to quiz a couple of experts who also happen to be friends: Marsha Simon and Tim Donner. (more…)

 
Jenny
Frank

Lifestyle Intervention and the Diabetes Prevention Program

Tuesday, August 3rd, 2010

On Monday, July 12, 2010 I attended the Pre-Diabetes Congressional Briefing on Capitol Hill held in cooperation with Congressional Diabetes Caucus Co-Chairs Rep. Diana DeGette and Rep. Mike Castle and co-sponsored by Results for Life, the American Diabetes Association, Novo Nordisk, and The Endocrine Society.  I was astonished to learn that there are 57 million Americans living in danger of developing type II diabetes.  For 40 percent of these individuals,  full blown type II diabetes is expected to be a reality in as few as 3-8 years. And diabetes is not their only concern. Diabetes translates to a 50 percent increased risk of heart disease or stroke and complications from hypertension, kidney disease, and neurological problems.

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The Debate Over the Use of Antibiotics in Animal Agriculture

Monday, July 26th, 2010

antibiotic-resistance-image

Last week I traveled to Capitol Hill to hear testimony before the House Committee on Energy and Commerce regarding the use of antibiotics in animal agriculture. After making my way through a crowd of PETA advocates and security, I entered the Rayburn Building and was shocked to find that there was already a line down the hall-I knew then I was in for an interesting afternoon.

So what was all the fuss about? The House Subcommittee on Health hearing on July 14th was focused on issues surrounding the industrial farming practice of routinely incorporating low dose concentrations of antibiotics in the feed and water of healthy food animals for growth promotion, feed efficiency, and other uses where the animal has not been exposed to disease. This is a topic my colleagues have discussed on the FSB in the past.

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Will BPA Bump Food Safety to Back Burner?

Friday, May 7th, 2010

With another food contamination outbreak in the headlines – this time E. coli-tainted romaine lettuce traced to an Ohio food company that has sickened at least 19 people- the question of how and when food safety legislation will move forward is more timely than ever. While the House passed its version of The Food Safety Enhancement Act last July, the Senate has been much slower to act. food-nutrition
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What’s Really on Our Dinner Plates?

Friday, April 16th, 2010

Industrial farming is a controversial and heavily politicized issue. For decades, our meat industry has stuffed animals raised for human consumption with antibiotics and pesticide-laced grains, and confined our soon-to-be chicken cutlets, bacon and filet mignons to small spaces, allowing for pathogens and microbes to manifest and multiply, while creating a bigger, fatter (more profitable) animal. Industrial farming practices have made meat more affordable, but at what cost to our health?  food_policy
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