Medical Devices and Prescription Drug Policy

Senate Majority Leader Harry Reid (D-Nev.) again moved a vote on a motion to proceed on a Food and Drug Administration reauthorization bill, saying the holdup over agreeing on which amendments to attach to the bill was on the Republican side.

Senate Majority Leader Harry Reid (D-Nev.) said Wednesday morning that the Senate is "very close" to reaching an agreement to advance a Food and Drug Administration (FDA) bill later in the morning.

"We're very close to being able to have an agreement, a path forward on this bill," Reid said in brief floor remarks. "That would be really a good thing for the country."

Senate Majority Leader Harry Reid (D-Nev.) warned that the Senate could move to other legislation if an agreement over amendments to a Food and Drug Administration bill could not be reached. 

A leading pharmacists group praised provisions of the Senate's FDA bill Tuesday that would probe whether law enforcement practices contribute to drug shortages.

The group's suspicion, also voiced by Sens. Chuck Grassley (R-Iowa) and Sheldon Whitehouse (D-R.I.), is that certain limits placed on drug manufacturers by the Drug Enforcement Agency (DEA) may lead to short supplies in medical environments and on shelves.

The DEA enforces the Controlled Substances Act by limiting the manufacture of certain medications.

"While most of the reported shortages to date have come from the institutional settings in the sterile injectable area, community pharmacies have also experienced shortages of certain medications," the National Community Pharmacists Association (NCPA) wrote to Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.).

Next week will see Senate action on a must-pass Food and Drug Administration (FDA) bill. Elsewhere, the topic at hand will be delivery system reform.

Congress has until the end of September to reauthorize the user fees that the FDA collects from drug and medical device makers. The Senate bill will also adjust some FDA policies with the goal of easing approval for life-saving drugs.

The White House backed the effort Thursday and praised the bill for creating a new user fee for the review of generic drugs.

 “Promoting innovation, safety, and access to medicines and devices is critical to the nation’s health, and the administration supports this bipartisan legislation that contributes to this goal,” the Office of Management and Budget said in a statement of administration policy.

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The Obama administration says it "strongly supports" the bipartisan Food and Drug Administration bill that the Senate began debating Thursday morning.

The legislation would reauthorize user fees the Food and Drug Administration collects from companies that make prescription drugs and medical devices. It also makes certain changes in FDA policy, aimed at bolstering oversight of drug safety and making it easier for the FDA to quickly approve potentially life-saving drugs.

"Promoting innovation, safety, and access to medicines and devices is critical to the Nation's health, and the Administration supports this bipartisan legislation that contributes to this goal," the Office of Management and Budget said in a Statement of Administration Policy.

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Reid made the comments as the Senate began debate on a bill to help the FDA approve drugs more quickly.

Sen. Bernie Sanders (I-Vt.) is pushing a bill to end exclusive marketing rights for new HIV and AIDS drugs and replace them with rewards of money from the government.

The measure would stop drug makers from setting high prices during the monopoly phases for new treatments, which reduces access to the drugs for many patients.

Sanders, chairman of the Senate subcommittee on Primary Health and Aging, noted that many HIV and AIDS patients die because they cannot afford antiretroviral drugs.

He cited one treatment, Atripla, that costs "more than $25,000 per person per year" in the United States. Its generic counterpart costs $200.

"The average American would be very upset to know people are dying not because we can't cure them, but [because of] the cost to save their life," Sanders said in a hearing Tuesday.

Federal Communications Commission Chairman Julius Genachowski will advocate releasing spectrum for wireless medical devices that can operate as "mobile body area networks," the FCC announced Tuesday.

Genachowski plans to speak at a Thursday event at The George Washington University Hospital in Washington, D.C., on the benefits of the devices.

A mobile body area network (MBAN) is a wireless system that uses low-cost wearable sensors that allow doctors to remotely monitor patent vital signs.

Congress is on track to pass an important healthcare bill quickly, easily and with bipartisan support in both chambers.

Yes, really.

The bill in question would reauthorize user fees that the Food and Drug Administration collects from the drug and medical device industries. Congress has to reauthorize the fees every five years, and the must-pass the bill often becomes a vehicle for other FDA legislation.

But, at least so far, this year’s negotiations have been remarkably smooth. The House Energy and Commerce Committee’s Health panel is meeting Tuesday to mark up the FDA bill, with a full committee markup scheduled just two days later. A companion bill is already awaiting floor debate in the Senate.

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