Health Reform Hub Issues

Issues :: Pharmaceutical

Rep. Erik Paulsen vows to revamp FDA and cut medical device tax
Brad Allen

MinnPost, 05/20/11

Minnesota’s 3rd District congressman, Erik Paulsen, who co-chairs the congressional Med Tech caucus, has an ambitious legislative agenda that would have a big impact on the industry. He said he is pushing for legislation to: 1) “Modernize” the Food and Drug Administration; 2) Block implementation of a $20 billion tax on medical devices; 3) And make the corporate research and development tax credit permanent.   Read more...

Avastin Debate in U.S. Exposes Inferiority of European Health Care
Alberto Mingardi

The Examiner, 05/16/11

Revocation by the U.S. Food and Drug Administration of Avastin for the treatment of breast cancer has sparked a degree of controversy in the United States that is disorienting to Europeans. For one thing, Avastin is still endorsed by the European Union. In March, European political authorities confirmed Avastin does enable women with metastatic breast cancer to live an additional several months -- or, sometimes, several years.  Read more...

A Devious Tax On Medical Devices
Sally C. Pipes

Forbes.com, 05/16/11

This summer the IRS is set to finish writing the rules for one of ObamaCare's new taxes--its 2.3% levy on medical device companies. Congress should wrest the pen from the taxman's hand and scrap the tax entirely. Not only will it raise the prices American patients pay for life-saving medical equipment, it will also destroy thousands of high-quality jobs across the country.   Read more...

Stalling the Engine of Economic Recovery
Grace-Marie Turner

RealClearMarkets, 05/13/11 

As America struggles to get people back to work after the deep recession, the best strategy is to focus on unleashing those industries most primed to create high-quality jobs, to innovate, and to strengthen our manufacturing sector so we can boost exports. President Obama apparently disagrees. The pharmaceutical industry fits the description of an industry ready to contribute to U.S. recovery, yet the president is proposing policies that will impede the industry's ability to do what it does best - innovate, generate big profits for shareholders, and create jobs in the process. He wants to make it more difficult for the industry to invest in cutting-edge medicines, and he also wants to replace industry-driven research with government-run research.    Read more...

Doctors, Not Politicians, Should Decide
Grace-Marie Turner

The Enterprise Blog, 05/10/11 


In Alex Brill's paper on "Overspending on Multi-Source Drugs in Medicaid," he writes about "the potential savings that could have been achieved had Medicaid consistently used the lower-cost version" of 20 multi-source drugs. While there is little or no debate about the need to control Medicaid spending, Brill's recommendations could lead legislators to conclude that they should tighten their formularies further, leading to adverse results for patients. Brill's study says that with the immunosuppressant Cellcept, doctors substitute a generic only 44 percent of the time and 68 percent of the time with the anticonvulsant Keppra. Yet many other drugs on his list have substitution rates in the 90 percentile. Clearly doctors are making decisions here about when a generic is appropriate and when it is not. The message policy makers surely will hear from Brill's paper is to strongly encourage the use of generics over brand-name drugs. But the longer-term costs, both to patients and the system, could be much higher when politicians, not doctors, are making decisions about patient care.   Read more...

Kathleen Spitzer

The Wall Street Journal, 05/02/11


Health and Human Services Secretary Kathleen Sebelius made her political name in Kansas, though we wonder if she's getting special advice from Eliot Spitzer. Her department's latest attack, on the CEO of Forest Laboratories, is straight out of the former New York Attorney General's bullying playbook. HHS this month sent a letter to 83-year-old Forest Labs CEO Howard Solomon, announcing it would henceforth refuse to do business with him. What earned Mr. Solomon the blackball? Well, nothing that he did—as admitted even by HHS.  Read more...

Patient Safety and ‘Off-Label’ Drug Use
Merrill Matthews

Forbes: Right Directions, 4/20/11


Off-label drug use is facing some headwinds.  Case in point: two new reports looking at off-label use of the hemophilia drug NovoSeven and two soon-to-be-released studies comparing the off-label use of Avastin vs. Lucentis for macular degeneration. While doctors use most prescription drugs as directed and approved by the U.S. Food and Drug Administration (FDA), they occasionally prescribe drugs to be used in ways not FDA approved, referred to as “off-label” use.  The FDA gives doctors that discretion as long as the off-label use seems reasonable. Read more...

ObamaCare: Still a Clear and Present Danger
Grace-Marie Turner

Real Clear Markets, 4/4/11


If only it were actually were true! According to a recent the Kaiser Health Tracking Poll, nearly half of Americans believe that ObamaCare either has been repealed or aren't sure. Just over half correctly understand that this government takeover of health care continues unabated. It's not surprising that people are confused. The House voted to repeal the law in January by a large margin, and headlines across the country read, "House votes to Repeal ObamaCare." People have read other headlines that say, "Court declares ObamaCare unconstitutional." And they have read news reports about numerous efforts in the House of Representatives to defund the law. Read more...

A Little Too Enterprising
Peter Pitts

Center for Medicine in the Public Interest: Drug Wonks, 3/30/11


According to a report in the Washington Post, “Medicaid, the joint federal-state health program for the poor, spent $329 million extra in 2009 purchasing 20 brand-name drugs instead of available generic copies, according to an American Enterprise Institute report.” The spending numbers are iffy. The word “extra” is wrong.  And words matter. A lot. The Post writes, “The study included contraceptives, respiratory medicines and antibiotics. Risperdal, New Brunswick, N.J.-based Johnson & Johnson’s antipsychotic, prescribed in generic form exclusively would have saved $60 million in 2009, the report released Monday found.” It’s important to note (and is mentioned in the Post story) that Teva (the world’s largest generic drugs company) makes a generic version of the drug. Read more...

Obamacare One Year Later
Fox News, 3/21/11



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