Medical Devices and Prescription Drug Policy

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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The Senate passed a major Food and Drug Administration (FDA) bill Tuesday, getting some bipartisanship out of its system before the Supreme Court’s explosive decision on healthcare reform.

The FDA bill passed the Senate 92-4. The same legislation passed the House by a voice vote earlier this month. President Obama is expected to sign the bill, which reauthorizes user fees that the FDA collects from drug and medical-device companies.

It also makes several changes to FDA policy, mostly geared toward bringing innovative products to market more quickly while bolstering the FDA’s safety oversight.

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The House easily approved legislation on Wednesday that would reauthorize the Food and Drug Administration's user-fee program for brand-name drugs and medical devices, and expand that program to cover biosimilars and generic drugs.

After a brief debate in which both parties praised their rare and cordial bipartisan effort, members approved S. 3187, the FDA Safety and Innovation Act, in a voice vote.

The House is scheduled to vote Wednesday on a must-pass Food and Drug Administration bill after House and Senate negotiators reached an agreement Monday on the legislation.

Majority Leader Eric Cantor's (R-Va.) office said the FDA bill is slated to come to the House floor Wednesday under special rules that require a two-thirds majority for passage. A Senate leadership aide said the upper chamber will likely take up the final bill next week.

The measure has broad bipartisan support in both chambers: The House passed an earlier version by a 387-5 vote, and a Senate version passed 96-1.

A bipartisan group of House and Senate lawmakers announced Monday evening that they had reached an agreement to reconcile their two bills. 

The House is expected to pass a bill this week that would significantly increase fines against people or companies that sell fake medicine in the United States.

The Counterfeit Drug Penalty Enhancement Act, H.R. 3668, could come up for a vote as early as Monday evening. Under the bill, people found to be trafficking in fake drugs would face fines as high as $5 million and prison terms of up to 20 years, or both, for a first offense. Repeat offenses could lead to penalties as high as $15 million and 30 years in prison.

Pharmaceutical companies don’t have to pay overtime to their salespeople, the Supreme Court said in a 5-4 decision Monday.

Federal law requires most employers to pay overtime to employees who work more than 40 hours per week, but the requirement does not apply to anyone who is employed as an “outside salesman.”

The court said drug companies’ salespeople fall under that exemption and therefore aren’t entitled to overtime pay.

The ruling is a loss for the Obama administration, which had argued that drug representatives do not fall under the definition of salespeople.

A House Republican asked the Obama administration's chief health official for her plan to avoid medical errors associated with the expansion of information technology in healthcare.

Rep. Renee Ellmers (R-N.C.) asked Health and Human Services (HHS) Secretary Kathleen Sebelius for a copy of the department's plan to "minimize patient safety risks" associated with health IT.

"I share your commitment to our nation's healthcare system," Ellmers, a nurse, wrote in a letter Tuesday.

Medicare discounts on prescription drugs could end if the Supreme Court strikes down the healthcare law, Kaiser Health News reports.

Murray Ross, director of the Kaiser Permanente Institute for Health Policy, says there is no easy substitute for the individual mandate to buy health insurance. KHN has the story.

Women physician researchers are paid $12k less on average per year than their male counterparts, a new study found. The Wall Street Journal has more.

Health officials in New York City are warning that a suction ritual included in some Orthodox Jewish circumcision ceremonies transmits herpes to infants. The New York Times has the story.

The city's board of health is strongly supporting Mayor Michael Bloomberg's (I) proposed ban on large, sugary drinks, according to The Associated Press.

A new study ties mindfulness meditation to positive changes in the brain. HealthDay has more.

Thursday marked the 30th time the House has voted to repeal or de-fund all or part of President Obama’s healthcare law. Like almost all of the previous 29, the bill to repeal the law’s tax on medical devices easily passed the House and will now go on to die a quiet death in the Senate.

Republicans were able to peel off 37 Democratic “no” votes for the device-tax repeal, which is unpopular with even liberal lawmakers whose states and districts are home to device companies. The bill also would repeal the Affordable Care Act’s restrictions on the use of health savings accounts. Both of those policies would increase the deficit, and would be offset by changing the way people have to pay back excess subsidies under the healthcare law.

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