Medical Devices and Prescription Drug Policy

Rep. Edward Markey (D-Mass.) is preparing to introduce a bill that would impose stricter regulations on drug compounders.

Markey's district includes the Framingham-based New England Compounding Center (NECC), the pharmacy operation linked to 28 meningitis deaths around the country.

The spate of illnesses has prompted questions about the NECC and other compounders, which reprocess drugs on a large scale to meet patients' special needs. The firms are not obligated to follow many rules that apply to drug makers, and congressional Democrats have blamed the meningitis outbreak on lax regulations. 

Leaders with the Senate Finance Committee are charging medical device maker Medtronic with manipulating studies on its spine-fusion product and failing to disclose significant financial ties to the studies' authors.

The allegations came as part of an investigation released Thursday by Finance Chairman Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) on practices at Medtronic.

The senators' final study alleged that Medtronic, in addition to substantially editing articles on its product, paid roughly $210 million to article authors for "consulting, royalty and other miscellaneous arrangements" between 1996 and 2010. 

Democratic lawmakers are sounding the alarm on a new hacking threat — to your pacemaker.

In a statement Thursday, three House Democrats called on the Food and Drug Administration (FDA) to scrutinize implantable medical devices more carefully.

The lawmakers cited government research showing devices such as cardiac defibrillators and insulin pumps can be vulnerable to tampering because of their wireless capabilities. 

Officials warned Tuesday that scam artists are posing as agents with the Food and Drug Administration (FDA) to extort money from people who buy medications online.

These "bogus" government agents reportedly gather consumers' personal information and call them demanding fines. Many scammers tell victims that purchasing drugs online or via phone is illegal and threaten them with physical harm unless payment is made.

"The call is likely a scam if the so-called agent directs you to send the money by wire transfer to a designated location, usually overseas, and if you are warned not to call an attorney or the police," the FDA alert stated.

Seven of the top 10 Medicare prescription drug plans (PDPs) saw a double-digit increase in premiums for 2013, according to an analysis by Avalere Health.

The increases mean that several of the top 10 PDPs will lose eligibility for low-income subsidy beneficiaries in some U.S. regions, the study found.

The release comes not long after the Kaiser Family Foundation reported that health insurance premiums rose by a modest 4 percent this year on average, down from a 9-percent increase in 2011. Analysts attributed the drop to the slow economy.  

While Avalere did not speculate on the reason for the Part D premium increases, the group warned seniors to look closely at their options for the come year. 

The Federal Trade Commission (FTC) on Thursday prohibited a mouthpiece manufacturer from making claims that its product reduces the risk of concussions.

Sens. Tom Udall (D-N.M.) and Jay Rockefeller (D-W.Va.) both applauded the settlement. Udall has made a push in recent years to increase standards of football helmets and reduce false safety claims made by manufacturers.

"Increased awareness of the dangers associated with sports concussions is extremely important," Udall said in a statement after the announcement. "But as the Brain-Pad settlement proves, some companies seem to be taking advantage of the fears of parents, coaches and athletes.”

Generic drugs have saved the healthcare system more than $1 trillion over the last decade, according to research released Thursday by the generics industry.

The industry is pushing for expanded use of generics in Medicare and Medicaid, and the new research suggests that generics have helped control the government's spending on prescription drugs.

"The analysis clearly demonstrates that any effort to reduce health care costs — whether on Capitol Hill or in state legislatures—must recognize the billions of dollars in savings that can be achieved through the use of generic medicines," the study says.

The legislation would make it easier for people to defend themselves in federal cases for possessing marijuana.

Federal regulators have approved the first drug to reduce the risk of HIV infection among people likely to be exposed to the virus.

The landmark move extends the approval of Gilead Sciences's Truvada, which is already in use as an antiretroviral by HIV-positive patients, to preventive use in combination with safe sex.

The drug's trial found that Truvada reduced the risk of HIV infection by 75 percent compared to a placebo, according to a release. 

The head of the Food and Drug Administration (FDA) praised in the approval in a statement.

President Obama on Monday signed the bipartisan Food and Drug Administration bill that Congress approved last month.

Obama signed the Food and Drug Administration Safety and Innovation Act, which reauthorizes user fees that the FDA collects from the drug and medical-device industries. The fees must be reauthorized every five years.

It also creates a new fee for companies that sell generic drugs, and it makes several changes to FDA policy, mostly geared toward speeding the approval of potentially life-savings products and bolstering the agency’s oversight of safety issues.

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