FDA's estimate that the agency would need a boost to medical device user fees by at least 17 percent over the level it is currently collecting to sustain programmatic operations has sparked concerns from industry, especially since it is possible FDA will indicate that even greater increases are necessary due to Republican efforts to cut its budget, according to sources and agency slides obtained by FDA Week. Industry's reluctance to pay higher fees stems from the agency's floundering performance in meeting review goals and because firms will soon begin paying health reform's excise tax.

A House lawmaker who has championed antibiotic development incentives legislation is eying adding exclusivity for antimicrobial biologics and products with companion diagnostics, according to draft legislation circulating among Washington insiders. The draft bill, which was obtained by FDA Week, also differs from a previous version of the measure in how it grants the additional exclusivity extension beyond both the patent and the Hatch-Waxman exclusivity period, and not just the latter.

House Republicans' proposal to slash the FDA budget could adversely impact how the agency protects the food supply from terrorist acts and curb planned collaborations with the Department of Homeland Security to stem intentional adulteration, according to food safety advocates. The food industry's top lobby group is also pushing FDA to allow both food defense and preventive control plans through the new food safety law and outlined its food security strategies in a recent closed-door meeting with FDA.

Physicians obtaining comparative effectiveness information from federal government drug detailers are embracing the new program that has been operational for only three months and the doctors are seeking more interaction on differences between various types of treatments, the private sector contractor for the program told FDA Week. The program's detailing efforts began on Feb. 22 regarding a form of insulin, and physicians have overwhelmingly engaged the detailers, which are academics and doctors, sources said.

The pharmaceutical industry recently lobbied a university-based center to obtain data on drug abuse to help firms fulfill their newly mandated Risk Evaluation and Mitigation Strategies requirements for pain killers, a situation that highlights how lawmakers are grappling with manufacturers' financial role in stemming the abuse of their highly addictive products. An advocate of prescription drug monitoring programs told Senate lawmakers this week that funding from drug companies should not be provided to individual states for their drug abuse prevention efforts that track usage, and instead firms should pay into a user fee-like structure that would disseminate funds to states to bolster their programs.

A recent federal appeals court decision could disincentivize small foreign firms -- and food importers in particular -- from relying on third parties to sell their products in the U.S. as the judge ruled the manufacturer can be held liable for any event world-wide, but an upcoming Supreme Court ruling in a separate case could provide protection against that ruling, according to an attorney following the cases.

The increasing utilization of smartphones could help firms implement Risk Evaluation and Mitigation Strategies by providing information to consumers who have grown more reliant on the technology, especially lower income patients who buy them in lieu of computers, a drug company risk manager said. Both FDA and manufacturers have been grappling with their role in sharing information using Web 2.0 tools like Twitter and Facebook, citing concerns with policing adverse event reporting and control over content.

The House FDA appropriations subcommittee approved funding legislation Tuesday (May 24) that would cut FDA's fiscal 2012 budget by $285 million compared to the fiscal 2011 spending level, accounting for an 11.5 percent reduction that is also more than 20 percent less than the president's request.

The medical device industry continues to generally oppose an FDA proposal that would make device photographs available in a public database, according to comments recently submitted to the agency. FDA offered the proposal among its recommendations to reform the 510(k) device clearance process and the concept was further discussed at a stakeholder meeting earlier this year.

The Congressional Budget Office is contending that a moratorium on direct-to-consumer drug advertisements, an idea floating on Capitol Hill, could lead to more pharmaceutical company detailing, marginally impact prescribing of certain products and therefore not affect costs substantially, and possibly adversely impact public health because consumers would not seek out an available treatment, according to a report released Thursday (May 26).

FDA would have to finalize the over-the-counter sunscreen monograph within 180 days of enactment of a Senate bill introduced Wednesday (May 25), with that measure also mandating a four-star labeling system to rate the strength of the product's protection. A similar bill is expected in the House, although House and Senate legislation addressing the delayed regulations has not advanced in previous sessions of Congress and an industry attorney said it is unlikely to gain support based on the contentious star rating system and bigger competing issues, like the debt ceiling.

In a slew of warning letters issued last week, FDA cracked down on companies making claims that their cigarettes posed less risk than other tobacco products. The agency and IOM are weighing how to address the issue of modified risk tobacco products, as claims like "low," "light" and "mild" were banned under the 2009 legislation that brought tobacco regulation under FDA's power.

A top White House drug policy official told members of the Senate Judiciary Committee Tuesday (May 24) that they should prioritize the prescriber training components of an administration plan to curb prescription drug abuse. An advocate of prescription drug monitoring programs further said the training should be connected to state efforts that track the dispensing of prescription drugs to prevent patients from obtaining addictive medications from several sources.

FDA is proposing to amend approximately two dozen policies spanning drugs, devices and food as part of an administration-wide effort to reduce burdensome regulations on states and firms, but the White House is already taking heat from stakeholders who note that some of the proposals will simply change regulations without actually making them less onerous. Republican lawmakers who asked for the plans last week and did not receive the documents by the requested date also chastised the White House for a lack of transparency.

FDA is extending the comment period on the health reform-mandate chain restaurant menu labeling proposed regulation by 30 days in response to requests to allow more time for consumer research and to assess the policy's impact, according to a Federal Register notice published Tuesday (May 24). The National Council for Chain Restaurants was one of the groups requesting the extension because its members are conducting studies on topics like menu readability at drive-through windows (see FDA Week, May 6).

Top Senate Finance Committee lawmakers want to know if FDA can mandate conflicts of interest disclosures in citizen petition procedures following findings that medical groups and physicians with financial ties to drug companies have lobbied FDA in support of drugmakers' interests. A Finance panel report on the issue spurred a government watchdog group to call on FDA to get a better grasp on the background of those lobbying the agency and request that disclosures of financial ties to pharmaceutical companies be made public.

The next revolution in personalized medicine, which has thus far largely impacted the development of cancer diagnostics and treatments, will occur in the diabetes and mental health realms, especially because of the strong genetic component to these illnesses, according to a cancer physician.

Democrats in both chambers are criticizing the price increase of more pharmaceuticals, which were widely available ahead of FDA approval but skyrocketed in price after the agency green-lit marketing of the drug, according to letters sent from Capitol Hill this week. This issue already garnered substantial attention earlier this year following the price hike of the pre-term labor drug Makena, which sparked congressional outreach and calls for an investigation.

A coalition of consumer groups is suing FDA to withdraw approval for the bulk of non-therapeutic uses of two animal antibiotics -- penicillin and tetracyclines -- because bacteria are growing increasingly resistant to these critical drugs. The lawsuit, filed under the grounds that FDA is violating the Administrative Procedures Act and its fundamental obligation to the public health, spurred a lawmaker supportive of animal antibiotic limits to call for FDA action to limit prescribing of these pharmaceuticals to healthy animals, while an animal drug industry source said the lawsuit ignores recent science.

The medical device industry is calling for FDA to exclude a slew of device types from its planned labeling repository, seeking exemptions for implantable devices and technically complex products, according to recent comments submitted to FDA following a stakeholder meeting on the issue earlier this year. Additionally, device firms contend that FDA should develop a mechanism to link to labeling information already provided on manufacturers' websites instead of developing a full repository and continue to push for FDA to initiate the effort by targeting devices used in the home.