MASSDEVICE ON CALL — Big pharma logged two important wins in the nation’s highest court yesterday, freeing prescription data for commercial sale and limiting lawsuits filed by people harmed by generic drugs.
The U.S. Supreme Court overturned a Vermont law banning "detailing" of prescription information collected by pharmacies, allowing drug companies to mine prescriber-identifiable prescription info to target marketing toward physicians based on the kinds of medicine they tend to prescribe.
The court ruled 6 to 3 in favor of the drug companies.
The plaintiffs in the case of Sorrell v. IMS Health argued that the Vermont law was a commercial free speech restriction, saying prescribing data helps them monitor the safety of new drugs and study treatment outcomes. State officials countered that drug companies were using the medical data as a "covert marketing tool."
Justice Anthony Kennedy, writing for the majority, said the Vermont ban infringed on fundamental First Amendment rights by restricting the use of truthful information, the New York Times reported.
"If pharmaceutical marketing affects treatment decisions," he wrote, "it does so because doctors find it persuasive. Absent circumstances far from those presented here, the fear that speech might persuade provides no lawful basis for quieting it."
Justice Breyer was joined by Justices Ginsburg and Kagan in dissent of the majority opinion, arguing that the Vermont law should have been upheld under normal standards for commercial speech.
"At best, the court opens a Pandora’s box of First Amendment challenges to many ordinary regulatory practices that may only incidentally affect a commercial message," Breyer wrote.
In the second case, Pliva v. Mensing, the court ruled that the makers of generic drugs can’t be sued under state law for failure to warn customers about risks associated with their medications.
Generic drugs make up about 75 percent of prescription drug use in the U.S. The ruled in a split 5 to 4 decision in favor of the drug companies.
The court ruled against drug makers in a similar case against brand-label drugs two years ago, according to the Times, based in large part on the fact that drug makers can sometimes change product labels without permission from the Food & Drug Administration.
It came from outer space
Scientists with the National Space Biomedical Research Institute (NSBRI) developed tools that expand the use of ultrasound during spaceflight and on Earth, especially in rural and underserved locations. Ultrasound technology is an important tool for health care in space where remoteness and resource limitations pose serious challenges.
"The ultrasound imagery techniques came from space program constraints of not having a trained radiologist on orbit or having a CAT scan or an MRI available, forcing us to use ultrasound for things in which we would not normally use it," said Dr. Scott Dulchavsky, chairman of surgery and surgeon-in-chief at the Henry Ford Hospital in Detroit.
"We demonstrated on the International Space Station that even non-physicians can produce diagnostic-quality ultrasound images using remote guidance," said Dr. Leroy Chiao, former NASA astronaut, chairman of the NSBRI User Panel and one of the first to conduct an ultrasound exam in space. "These ultrasound exam techniques and atlas will be increasingly important as we venture farther and longer into space. Telemedicine using ultrasound will be an invaluable medical diagnostic tool."
Singapore establishes a nationwide EHR system
In line with Singapore’s "one patient, one record" vision, Accenture plc (NYSE:ACN) and MOH Holdings Singapore launched one of the world’s first national electronic health record systems, EMR Daily News reported.
Health care providers will be able to access a single patient record that captures medical data, including patient demographics, diagnosis, medications, tests, procedures and discharge summaries.
Consumers fight against new HHS rules on insurance appeals
Consumer advocates are fighting back against revised regulations on the appeal process for denied insurance claims, Healthwatch reported.
The Dept. of Health and Human Services had initially proposed a 120 day window for consumers to request an external review for an insurance denial, but the department shortened that to 60 days. The new guidelines also give insurers 72 hours to review urgent claims, three times longer than the initial rule.
Mass. Life Sciences Center announces Summer 2011 startup loan program
The Massachusetts Life Sciences Center announced the launch of their Summer 2011 Accelerator Loan Program, the center’s flagship investment program providing working capital to early-stage life sciences companies. The program offers loans up to $750,000 per company and has awarded $9.2 million in unsecured deb financing to date.
Applications are due by noon EST on August 5, 2011.