Archive for the ‘Health Policy’ Category

Erika
Ackerman

A few mornings after the “morning after” decision

Wednesday, June 19th, 2013

PB

Last week, the Obama administration announced it will cease its attempts to block over-the-counter availability of the Plan B One-Step pill. It seems likely that an intense backlash is going to follow.

There is nothing Americans like more than to debate about public policy.

As expected, there has been a public up-roar on social media sites. There are varied responses across the blogosphere. Many bloggers and high-profile tweeters are asking the public, “Do you think the #MorningAfterPill should be available to girls of any age?” (more…)

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Allison
Stoll

What makes the life of a child life less significant than the life of an adult?

Friday, June 14th, 2013

aaCurrent organ transplant laws dictate that on the adult transplant recipient list, adults are given priority over children under the age of 12, regardless of how urgent and severe the child’s case.

Campaigning for Fairness = Winning

The Murnaghan family of Pennsylvania recently brought light to the issue of unfair preferential treatment for adults on transplant lists. Sarah Murnaghan, age 10, had a severe case of cystic fibrosis. She would have died within weeks had she not received a lung transplant. She had been at the top of the pediatric waiting list for over 18 months, but the chances of receiving a child’s lung were slim, as they are very rare. (more…)

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Mary Ellen
Hackett

Can “Isolated” Human DNA Be Patented? U.S. Supreme Court Set to Decide Pivotal Case

Monday, April 15th, 2013

DNAAsk a friend or colleague to name a landmark Supreme Court decision, and many might cite Roe v. Wade or perhaps Dred Scott v. Sandford, from 1973 and 1857, respectively.

Fast forward to the present: All eyes in the scientific community will be on the U.S. Supreme Court on Monday, when the justices will consider a question that poses huge consequences for research and innovation, and immeasurable reward for scientific discoveries.

In Association for Molecular Pathology v. Myriad Genetics, the Court will ultimately determine whether human genes can be patented. (more…)

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Jenna
Lenskold

We personalize our wardrobes, iPhones and homes. Why not our medicine too?

Wednesday, February 6th, 2013

Personalized medicine: treatments and medications tailored specifically for an individual.Earlier this week the Personalized Medicine Coalition (PMC) released “Pathways for Oversight of Diagnostics,” a discussion of regulation  surrounding personalized medications. Spectrum is a proud member of PMC, a thriving association focused on spreading awareness of personalized medicine.

How is medicine personal?

Personalized medicine is exactly what it sounds like: treatments and medications that are designed specifically for each individual patient. Personalized medicine exists in all health care arenas. When a patient gets diagnosed with cancer, a treatment plan must be created. Does chemotherapy work better or should the patient undergo surgery? Maybe a combination of both? In physical therapy offices, patients are prescribed a tailored exercise regime. Doctors personalize medicine every day when they prescribe unique dosages of a medication to sick patients. For example, a 250-pound man may need a stronger prescription dosage than a 10 year old boy. (more…)

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Amanda
Sellers

A Path to Relieve the Pain – FDA’s Draft Guidance for Abuse-Deterrent Opioids Sets the Tone for Another Year of Collaboration and Problem-Solving

Friday, January 11th, 2013

FDA is making efforts to diminish opioid misuse and abuse.Over the past few weeks, FDA has been applauded by many for the efficiency and timeliness of 2012 drug approvals, along with several initiatives, such as the “Breakthrough Therapy” designation announcements with Vertex Pharmaceuticals. This progress in product approvals, overall Agency efficiency and the move to collaborate with industry to push science and much needed treatments forward is a welcome harbinger for 2013.

And, to kick-off 2013, FDA released its Draft Guidance for Industry – Abuse-Deterrent Opioids – Evaluation and Labeling, which represents one more proactive step in addressing the challenges of managing pain appropriately, while minimizing the risks of misuse and abuse in society.

(more…)

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John
Seng

No Thanks, Big Tobacco

Monday, November 12th, 2012

Deskside Chats with John Seng No thanks, Big Tobacco.

Click the image to view my video blog.

Last month, I attended the Global Tobacco Briefing hosted by the American Cancer Society (ACS) and World Lung Foundation, as invited by my daughter Victoria Seng, an associate specialist with ACS’s Cancer Action Network (CAN) here in Washington.

Listening to global experts shed light on the health and economics that the tobacco industry would rather we not know was a real eye-opener for me during the morning National Press Club briefing.

Suffice to say, tobacco companies prolong preventable epidemics in cancer, heart disease and other conditions by exploiting trade agreements and abusing local legal systems throughout the world. (more…)

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Anthony
LaFauce

Tackling a Weighty Issue: Spectrum and GLOBALHealthPR Alarmed by Childhood Obesity Findings

Wednesday, September 12th, 2012

The evolution of Health 2.0 in our data-driven world calls for a shift in the way health organizations connect with their target audiences. On a global scale, there is enormous potential to make an impact through digital communications tool and technologies. Before making a change, however, it is necessary to understand who is saying what, and where the conversations – or lack thereof – are happening.

For our most recent initiative of tracking and scrutinizing online conversations in the spirit of improved public health, we focused on the issue of childhood obesity. In the U.S., experts say 42 percent of people will be obese by 2030. But many people don’t realize this isn’t just an American problem—it’s a problem across the world. Our team collaborated with our partners around the world on an exciting one-month survey of seven countries, looking at how the digital conversation on child obesity stacked up in Argentina, Australia, India, Portugal, the U.K., Mexico and the U.S. (more…)

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Amanda
Sellers

PDUFA: Rounding Third, Headed Home

Friday, June 29th, 2012

President Obama got in a little hot water earlier this week when he brought up the Boston Red Sox trade of Kevin Youkilis to the Chicago White Sox while hosting a Boston fundraiser. It wasn’t that great of a decision to bring up this unpleasantness with angry Red Sox fans, but now he has a chance to redeem himself and help an important piece of legislation slide across home plate, figuratively speaking.

Earlier this week, the Senate passed the updated PDUFA legislation that was developed and passed the House earlier in the year. Now that the bill has passed the Senate, it’s on to the POTUS (I want to see how many D.C. acronyms I can get in here). As a refresher, PDUFA is one of the many Washington acronyms that almost no one else outside of the health care world knows – it stands for Prescription Drug User Fee Act. If you need the PDUFA Cliff Notes check out my last blog post and check out FiercePharma and Washington Post for more coverage on what it all means when in practice. 

So, what does PDUFA really mean? It means that the FDA will have more resources to process drug applications, including the new additions of generic drugs and biosimilars (more affordable versions of biologic drugs) to the mix. This is great news for not only the FDA, but for the companies pushing innovation in medicines and new treatment options. But, most importantly, patients will reap the greatest benefit from this legislation. This is one piece of legislation that touches everyone in the U.S. who currently takes a prescription medicine or will take one in the future — which should be just about everyone. Quicker, more efficient review times without a heavy financial burden on the system is positive progress enough, but providing patients with a wider range of better treatment options is the best outcome anyone could hope for.

President Obama, since you’re on a roll with health care legislation, please give this legislation your stamp of approval too. Lots of folks are counting on this for another five years of PDUFA!

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Lissette
Capati

Media Commentary: Quick On the Draw, Off On the Mark

Thursday, June 28th, 2012

(Photo Illustration by Gary He)

So it’s out there. Everyone’s talking about it. CNN (and Fox News TV) screwed up big time – reporting that the Supreme Court ruled the Affordable Care Act unconstitutional when in fact, it was the COMPLETE opposite. How now brown cow? When online reporting and the 24 hour news cycle go horribly wrong? On the upside, they corrected the news…seven minutes later.

I’m going to go out on a limb here to say I miss the days of old school reporting – when journalists had time to make sure they got it right, when we would actually pick up a hard copy newspaper and read a…gasp…book. It’s the pressure of today’s news cycle. And the world we live in. Be the first one out. Get them tuned in. But we’re talking about a 193-page Supreme Court ruling on an expansive piece of legislation.

Lesson learned (this is for all of us):

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Luke
Dickinson

Supreme Court Upholds the Affordable Care Act

Thursday, June 28th, 2012

President Obama signs the Affordable Care Act into law in 2010

Amid great anticipation, fanfare – and even a belly dancer – the Supreme Court of the United States (SCOTUS) announced a 5-4 ruling to UPHOLD the constitutionality of the Affordable Care Act (ACA) – the health care reform legislation passed by President Obama in March 2010.

Question of Constitutionality

The ruling hinged on the question of constitutionality of the law; particularly the clause that would require Americans to purchase health insurance. The Court ruled that while it is unconstitutional for the government to command citizens to purchase insurance, as a part of its power to regulate commerce between states, five Justices agreed that Congress DOES have the authority to levy a tax on those who do not purchase insurance. As cited in Footnote #11, on page 44 of the 193 page ruling, this is laid out as:

“Those subject to the individual mandate may lawfully forgo health insurance and pay higher taxes, or buy health insurance and pay lower taxes. The only thing they may not lawfully do is not buy health insurance and not pay the resulting tax.” (more…)

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