Outcomes in two key cases, among those monitored for their discussion of off-label promotion, did not provide anticipated insight into commercial speech issues, with one case resulting in a government settlement and another leading to a decision hinging on other aspects of the case. The court results this week come months after an appeals court overturned an off-label promotion conviction, a result that is still being debated for its impact on FDA regulation. But there are no other similar cases on the horizon after court action in recent years.1018 words

FDA plans to phase in a structured qualitative framework for assessing the benefits and risks of drugs, starting with the review of applications for drugs containing a new molecular entity and original biologics during fiscal year 2014 and 2015, according to a draft plan released by the agency this week. The five-year plan fulfills a requirement in the FDA Safety and Innovation Act for FDA to consider medicines' benefits as a major part of the approval process. In addition, the framework provides for the first time a clear look into FDA's decision-making process, which patient groups have been seeking, according to a source.1243 words

A bicameral duo of Republican lawmakers has written FDA a second letter in three months questioning the agency's lack of guidance on testing requirements for generic opioids based on abuse deterrent innovator drugs. The lawmakers' questions -- contained in a letter obtained by Inside Health Policy -- track with those included in a citizen petition resubmitted by Purdue Pharma that also seeks specific testing requirements for abuse deterrent painkillers. Yet an industry attorney said the agency's general uncertainty on abuse deterrence and issues like labeling requirements could be hampering action on further guidance.1056 words

FDA is urging physicians to participate in voluntary opioid prescriber educational programs that kick off this month by sending letters to key physician groups, including those that have resisted efforts to make the training mandatory.377 words

Drug patent settlements between brand-name drug manufacturers and generic companies that file the first application for a product do not insulate patents from additional court challenges, the Generic Pharmaceutical Association said in a recent Supreme Court brief. The arguments espoused by GPhA continue a long-standing disagreement between the generic drug industry trade group and generic drug manufacturer Apotex. The company argues that reverse payment settlements discourage patent challenges as generic companies that do not settle with a brand name company do not have the same market incentive -- 180 days of exclusivity -- as the initial generic challenger (see FDA Week, Feb. 8).1110 words

Pew Charitable Trusts is urging FDA to remove language codifying in regulation a list of raw fruits and vegetables exempt from the proposed produce safety rule standards because they are subject to a "kill step," and instead include that list in a guidance document so the agency can react quickly to evolving information and emerging foodborne illness outbreaks. The request comes as consumer groups and a leafy green audit program raise concerns about exemptions for commodities like kale, which are now more likely to be eaten raw. The agency said it based the list on authoritative reports on food consumption patterns, but will consider how to refine the provision in light of stakeholder comments. 739 words

The House Wednesday (March 6) passed a continuing resolution funding the government through the end of the fiscal year and allowing FDA to fully collect medical device and generic drug user fees that were absent in previous funding measures. The measure would allow FDA's device center to spend $40 million in fees but it does not include a $24 million increase for FDA requested by the Obama administration.605 words

Rare disease stakeholders are joining forces to write a white paper they hope FDA can use as part of its forthcoming accelerated approval guidance, which is due later this year under an FDA Safety and Innovation Act mandate. The effort, although not spurred by the current fiscal environment, could be a useful model to help FDA balance budget cuts with needed additional guidance, an industry source said as rare disease advocates prepare for across-the-board cuts to unravel recent gains under the new law.666 words

FDA needs direction from Congress, preferably through legislation, emphasizing the importance of regulatory science in the agency's decision making processes, a group of science advisers recently told FDA following an assessment of science activities in the medical device center. Further, members of FDA's Science Board recommended more targeted research projects based on how they drive the center's regulatory mission and if they are unable to be done elsewhere.830 words

Freezing of nonessential positions and solicitations -- such as an FDA social media contract -- could prevent agencies from having to furlough employees as a result of sequestration, Sen. Tom Coburn (R-OK) said this week as he called on the White House Office of Management and Budget to put pressure on government agencies to increase scrutiny of all hiring activities in order to avoid furloughs of mission-critical positions.415 words

The House Monday (March 5) passed the Pandemic and All-Hazards Preparedness Reauthorization Act by a 370-38 vote, an expected move after the bill sailed through the Senate last week.153 words

FDA is reaching out to veterinarians and the animal agriculture industry to discuss plans to put more antibiotics under the watch of veterinarians, with the agency hoping to talk about the challenges in areas that lack access to veterinary services, FDA said Wednesday (March 6) in announcing five upcoming meetings. FDA is pressing ahead on its new animal antibiotic policies as stakeholders gear up for debate in Congress this year over reauthorization of the animal drug user fee law, with the agency-industry negotiated pact including plans to analyze reviews of drugs used in combination in light of the forthcoming veterinary requirements.662 words

The FDA drug center's Office of Translational Sciences is undergoing several organizational changes, including the creation of a new Office of Computational Science as well as several new hires, Center for Drug Evaluation and Research Director Janet Woodcock said in an internal memo sent Monday (March 4). The new office will lead and manage changes to the center's scientific computing abilities and operations, and provide oversight of CDER's Computational Science Center, which is designed to help reviewers provide more targeted services for the evaluation and analysis of study data.441 words

FDA plans to inspect about 30 compounding pharmacies known to produce sterile drugs, a move lauded by a senator who pressed the agency to ramp up oversight in the wake of the nationwide meningitis outbreak tied to drug compounding.269 words

Cubist Pharmaceuticals received another qualified infectious disease product (QIDP) designation for its antibiotic candidate ceftolozane/tazobactam to treat hospital-acquired and ventilator-associated bacterial pneumonia, and complicated urinary tract infections. The product previously received a QIDP designation for its complicated intra-abdominal infection indication. Stakeholders are closely watching to see which products qualify for the new GAIN designation.129 words

A coalition of 277 groups representing small farms and businesses is highlighting challenges with an FDA food safety rule's requirements for water and soil as it seeks more time to comment on the proposed regulations, which also include record keeping requirements that could take a toll on small businesses. The request comes on the heels of public meetings on the proposal where one consumer safety advocate also raised concerns about how well FDA is working with small farms to ensure compliance and the use of alternatives to proposed methods.1110 words

FDA should clarify how it plans to oversee farms exempt from the requirements of its proposed produce safety rule, who qualifies for small farm exemptions and the agency's process for tracking and revoking exemption status, industry and consumer groups said at a recent public meeting. Some stakeholders said the proposed rule's lack of clarity on what would be defined as a farm could be problematic for those working in cooperatives and raised questions about FDA's process for revoking or reinstating small farm exemptions. The Center for Science in the Public Interest, meanwhile, urged the agency to beef up hazard analysis requirements and consider a mandatory registration process for exempt farms.1022 words

Republican House members said they are concerned smartphones, tablets and mobile applications will be subject to taxes under the Affordable Care Act if FDA decides to oversee them as medical devices. Such a move would hamper innovation and economic benefits in the U.S. mobile marketplace, the lawmakers say in a March 1 letter to FDA.449 words

A former Senate health committee staffer said provisions on Risk Evaluation and Mitigation Strategies, patent settlements and a drug track and trace system -- amendments that failed to make it into the FDA Safety and Innovation Act -- could be again floated as Congress debates the animal drug user fee bill and looks for ways to reduce federal spending. However, movement on the creation of a federal track and trace system is unlikely, the former staffer said.538 words

Stakeholder groups are increasingly looking at taxation of sugary beverages as a way to nudge consumers toward healthier behaviors and glean revenues that could be targeted toward health education or prevention services, or even as a way to offset the cost of Medicare physician payment reform. John Rother, president and CEO of the National Coalition on Health Care (NCHC) tells Inside Health Policy that a sugar tax should be considered as a viable offset, and according to recent estimates a one-cent per ounce tax on sweetened beverages could bring in $150 billion over 10 years, which would more than cover the $138 billion cost of repealing the Sustainable Growth Rate formula used to pay physicians.793 words

Jay Taylor, vice president of international affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), recently highlighted three major patent problems that U.S. companies face in Canada.447 words

A new network collecting electronic patient statistics and information on physicians working in ethnically diverse communities could reduce the cost of clinical trials by easing recruitment and helping companies produce safe and effective drugs for the growing minority population, sources involved with the project said. The new network, which is a collaboration between the National Minority Quality Forum and Microsoft, comes as FDA must fulfill FDA Safety and Innovation Act mandates to analyze how various patient subgroups -- including those defined by sex, age, race and ethnicity -- are included in clinical studies and how that data could be translated into labeling.757 words