Medical Devices and Prescription Drug Policy

The FDA is coming under increasing political pressure from the White House, The New York Times reports.

Health insurers are breathing easy after the Supreme Court arguments, writes Reuters.

Health insurers are changing their business practice regardless of what happens to the healthcare reform law, reports Kaiser Health News.

Health statistics help shape local policies, writes USA Today.

Scientists can't predict most diseases for most people by mapping their genome, reports The Wall Street Journal.

The top Republican on the Senate Judiciary antitrust panel on Monday applauded the Federal Trade Commission's approval of the merger between pharmacy benefit managers Medco Health Solutions and Express Scripts.

Federal antitrust regulators on Monday approved a $29 billion merger creating the nation's largest manager of prescription drug benefits despite widespread congressional objections.

Express Scripts and Medco Health Solutions announced the completion of their merger immediately after the Federal Trade Commission gave its approval. More than 80 members of Congress, lobbied by pharmacies in their districts, have weighed in against the merger and raised concerns that it could lead to fewer choices for consumers.

"Our merger is exactly what the country needs now," George Paz, chairman and CEO of Express Scripts, said in a statement. "It represents the next chapter of our mission to lower costs, drive out waste in healthcare and improve patient health. We remain focused on formulary management, channel management and closing gaps in care, which will allow us to further improve the health of people with chronic and complex medical conditions."

The FTC voted 3-1 to allow the merger to go forward following an eight-month review that "revealed a competitive market for PBM services characterized by numerous, vigorous competitors who are expanding and winning business from traditional market leaders."

States would have a standard system to share information about prescription drug trafficking for the first time under legislation introduced Thursday. 

A bipartisan group of House and Senate lawmakers introduced the measure in response to calls from state lawmakers, many in the southeastern United States, who have cracked down on so-called "pill mills" during the past two years. 

The federal bill would link states' individual prescription drug monitoring programs, allowing doctors to see if a new patient has a history of abuse in another state before issuing a prescription.

Drug retailers sued Thursday to prevent a proposed merger between two giant pharmacy benefit managers that has prompted a groundswell of congressional opposition.

The trade groups representing chain drug stores and community pharmacists joined nine retail pharmacy companies in challenging the merger between Express Scripts and Medco Health Solutions. The Federal Trade Commission is currently reviewing the merger to make sure it doesn't violate federal anti-trust law.

"Community pharmacies have aggressively engaged in opposition to the merger — at the executive level through meetings and communications with the FTC and state attorneys general; and at the legislative level by testifying before the House and Senate," the trade associations said in a joint statement. "Engaging with the courts is another component in that process."

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Republican Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) urged Congress to keep a close eye on the Food and Drug Administration after a government report found that review times for medical devices has "increased substantially in recent years."

The two senators presented the Government Accountability Office report during a Senate hearing on medical device user fee legislation, which expires Sept. 30. The report found that the agency is meeting its review time goals under existing user fee legislation, but that those review times exclude the time it takes companies to comply with the agency's requests for more information.

"The GAO oversight report released today confirms a disturbing trend: the FDA is taking longer and longer to make final decisions on life-saving medical devices," the senators said in a joint statement. "This report makes clear that reporting only on the user fee performance goals negotiated by industry and the FDA does not paint a full picture of FDA's performance. GAO's report shows that FDA's final decisions on devices are taking longer due to more review cycles and requests for additional information."

A $3 billion hit on the medical device industry — roughly the effect of the healthcare reform law's industry tax — would cost nearly 39,000 jobs and more than $8 billion in economic output, according to a new report released Monday by the Advanced Medical Technology Association (AdvaMed).

The Battelle report aims to put pressure on lawmakers to repeal a medical device tax that is slated to go into effect next year. The tax, one of several new healthcare sector fees created by President Obama's reform law, would raise $20 billion over 10 years to help pay for the law's insurance subsidies and Medicaid expansion.

Defenders of the tax say its effect would be minimal because devices are usually covered by insurance, which doesn't respond much to price changes. In addition, the healthcare reform law would add millions more people to the insurance rolls, potentially drumming up business for the industry. Read more...

The Supreme Court's patent rejection is causing alarm in the biotech industry, The Wall Street Journal reports.

A U.S. soldier's shooting spree in Afghanistan has refocused attention on head trauma, the signature injury of the Iraq and Afghanistan wars, reports MedPage Today.

A House panel debated the merits of overtime and minimum wage protections for home health workers, Kaiser Health News reports.

The Washington Post delves into racial disparities surrounding breast cancer.

Thomson Reuters is nearing a sale of its health business, The Wall Street Journal reports.

Watchdog and medical groups have asked the Federal Trade Commission (FTC) to investigate vaccine “bundling” by two major drug companies.

In a letter sent to the FTC, the groups allege that Merk and Sanofi Pasteur are giving doctors a choice between purchasing bundled vaccines at a discount or paying “exorbitantly high prices to purchase vaccines individually.” 

“When parents take their kids to the doctor, they expect the best medical care available, not the care dictated by drug companies seeking to maximize their profits,” said Melanie Sloan, director of Citizens for Responsibility and Ethics (CREW) in Washington, in a statement. “Basically, doctors are asked to make a choice they can’t refuse.”

The Senate Judiciary Committee passed bipartisan legislation Thursday morning that would enhance penalties for stealing prescription drugs and medical devices.

The so-called SAFE DOSES Act aims to curtail the black market for stolen medicines by cracking down on pharmacy robberies and the heft of medical product cargo. 

Such thefts have skyrocketed in recent years, according to the government, putting consumers at risk of buying adulterated or poorly cared for medical products that might not be effective.