Medical Devices and Prescription Drug Policy

House lawmakers have introduced legislation to reduce the backlog of 2,000 generic drug applications that have piled up at the Food and Drug Administration.

The Generic Drug and Biosimilars User Fee Act calls on generic drug makers to pay about $1.5 billion over the next five years to help fund the federal regulators who review and approve new drugs. 

It would also enable the FDA to implement a pathway for approving generic versions of complex biologic drugs, which was made possible for the first time by the 2010 healthcare reform law.

A new government report is spurring calls for more price transparency for medical devices.

The Government Accountability Office found "substantial variation" in the prices hospitals paid for devices. The report concludes that pricing secrecy limited the ability of hospitals to negotiate for the best price, possibly leaving Medicare on the hook.

"The lack of price transparency for the [implantable medical devices] we examined makes it difficult to know whether hospitals are achieving the best device prices," the GAO report concludes. "This lack of price transparency may have implications for Medicare because excess or unnecessary IMD costs that hospitals incur may be passed on to the Medicare program."

The senior Republican on the Senate Judiciary Committee is demanding answers from the Obama administration over the Food and Drug Administration’s retaliation against whistleblowers who made contact with his office.

Six current and former FDA employees sued the government last week alleging that the agency pried into their personal email accounts and retaliated against them after they shared with Congress concerns about the approval process for medical devices. 

Sen. Chuck Grassley (R-Iowa), a longtime champion of whistleblower rights, on Thursday released a letter that warns that FDA officials could be breaking the law by retaliating against the whistleblowers, at least one of whom was fired.

The Planned Parenthood Action Fund launched a TV ad Wednesday that praises the Obama administration for sticking to its requirement that insurance plans cover birth control without co-pays or deductibles starting this year.

The final regulation, announced two weeks ago, created an uproar because it forces religiously affiliated hospitals and universities that serve the broader public to comply within one year. Many of those institutions already cover birth control, and a majority of women told pollsters they approve of the no-cost mandate.

Republicans, however, slammed the mandate as an assault on religious freedom, even though it exempts churches, synagogues and other houses of worship.

Medical device makers have reached a tentative deal with the Food and Drug Administration allowing the agency to collect $595 million in user fees over the next five years, both parties announced Wednesday.

The fees, which need to be approved by Congress, provide a dedicated revenue stream to pay for the federal regulators who review and approve new medical devices. 

The current five-year agreement expires Sept. 30, and industry and regulators had been at odds over the length and complexity of the approval process, particularly for low-risk devices.

The Food and Drug Administration secretly monitored emails sent by its own scientists on their personal accounts after they warned Congress that the agency was approving potentially unsafe medical devices, The Washington Post reports.

The documents in a lawsuit against the FDA filed last week are available here.

Newt Gingrich on Sunday called for a commission to study the ethical issues relating to in vitro fertilization clinics, The Associated Press reports.

South Florida voters aren't big fans of President Obama's healthcare law — even though many have no idea what's in it, Kaiser Health News reports.

More than 83 percent of U.S. citizens live in urban counties and 16.7 percent in rural ones, says the CDC, with important ramifications for health policy.

President Obama's healthcare law will save states and taxpayers $17.7 billion on prescription drugs, the administration said.

Federal agencies need to better track whether their efforts to educate painkiller prescribers about the risk of drug abuse are working, the Government Accountability Office said in a new report.

The report comes as the government seeks to crack down on prescription drug abuse, which now causes more deaths than cocaine and heroin combined. 

Several agencies have developed strategies that include "developing continuing medical education programs, requiring training and certification in order to prescribe certain drugs, and developing curriculum resources for future prescribers," the report says. And the Office of National Drug Control Policy is developing legislation requiring education for prescribers registering with the Drug Enforcement Administration (DEA) to prescribe controlled substances.

For the first time, an experimental treatment made from human embryonic stem cells has shown evidence of helping someone, The Washington Post reports.

The comparative effectiveness research body created by President Obama's health law "doesn't single out any specific diseases, treatments or procedures" to study in its draft priorities, Kaiser Health News points out.

The healthcare law's controversial advisory board charged with recommending Medicare rates will have a tough time functioning even if Republicans fail to repeal it, Politico writes.

Hospitals and clinicians that have failed to obtain federal incentives for adopting electronic health records or want to challenge a payment can now look to the Medicare agency for guidance on appeals, Modern Healthcare reports (subscription required).

Sixty-eight provider groups wrote to the bipartisan conference committee urging them to use war savings to pay for a permanent repeal of the flawed Medicare physician payment formula, Inside Health Policy reports (subscription required).

Employees of the privately owned drugmaker Stiefel say owners sought to buy their shares of the company on the cheap shortly before selling it to pharmaceutical giant GlaxoSmithKline in 2009, The Wall Street Journal reports.

Democrats on the Energy and Commerce Committee on Friday renewed their call for a congressional probe into two healthcare products amid partisan squabbling over the federal approval process for medical devices.

The panel Democrats first requested hearings on the "Lap-Band" weight loss device and urogynecologic surgical mesh in October. They say the two products have developed "serious defects" after being implanted in patients.

The larger goal of the hearings, however, is to shed light on concerns Democrats and patient advocates have with the safety of the federal approval process for medical devices. 

A scandal in France over faulty breast implants could derail medical device makers' calls for faster FDA approval in this country, Bloomberg reports.

Consumers in Massachusetts are confused by new "tiered" health insurance products, Kaiser Health News reports. 

A small group of states is running way ahead of the rest in setting up health insurance exchanges, Stateline.org reports.

His opponents ripped into Mitt Romney at a Personhood USA forum Wednesday after the front-runner declined to attend the anti-abortion-rights event, Politico reports.

Home medical equipment suppliers are trying to get an alternative to the Medicare competitive bidding program included in pending doc-fix legislation, Inside Health Policy reports (subscription required).

Healthcare giant Kaiser Permanente is converting its intravenous equipment to more eco-friendly alternatives, The Washington Post reports.