Increased agreement between FDA and the generic drug industry over a structure for the generic drug user fee program has put some pressure from a key lawmaker and other stakeholders on brand-name pharmaceutical manufacturers to support paying a fee to fund foreign inspections, although a brand-name industry source noted that these medicine makers have for nearly two decades paid fees for many activities -- including inspections -- to support the safety of these products. While the FDA-generic drug industry agreement is still not yet fully complete, the parties are now backing some principles -- including adding a product backlog fee -- as the final elements of the pact are negotiated before transmittal to HHS, the public and ultimately Congress for approval.

Five tobacco companies are challenging FDA's new graphic warning label requirements for infringing on commercial speech rights, citing a recent landmark Supreme Court pharmaceutical data mining case that is expected to have major implications for FDA's off-label medical product promotion policies and impact the logic used in a drug advertising case ripe for a ruling later this year. The tobacco firms said Tuesday (Aug. 16) that the government can discourage smoking, but it is unconstitutional to force companies to dissuade consumers from buying their products by requiring large warnings and graphic depictions.

FDA might begin considering unknown, long-term risks and will assess novelty when making benefit-risk determinations for high-risk medical products examined through the premarket approval process, according to new draft guidance, leading sources to suggest that these delineations -- outlined in such a manner for the first time -- mark policy shifts not previously expressed by the agency.

A new Facebook policy preventing companies from blocking user comments on pharmaceutical pages is forcing drug firms to bolster adverse event monitoring, as start-up companies are emerging and established marketing firms are evolving to address industry concern that the open dialogue could run afoul of off-label speech and other regulations in the absence of FDA social media guidance. The Facebook policy has also raised questions about the evolution of companies' online sponsorships and the agency's regulatory jurisdiction outside of product-specific pages.

A recently established drug and media industry coalition is planning to release voluntary social media guidelines in absence of long-delayed and highly-sought FDA action to clarify speech policies in this area. The Digital Health Coalition also plans to issue best practices for different social media platforms, going beyond the forthcoming agency guidance, which will to address broader content issues, as opposed to specifics on the rapidly changing Web tools.

FDA's discussion with the drug industry on draft statutory language to create a system that would mandate the agency spend appropriated dollars on the healthcare reform-created biosimilars pathway before expending user fee money has some sources questioning whether that discussion is appropriate in the context of implementing a statute, whereas FDA argues that the talks are necessary for providing the proper assistance to Congress and in line with other user fee processes.

FDA funding advocates have begun taking their message of the agency's importance to businesses, patients and consumers directly to lawmakers' districts, launching a campaign to both thank and educate members of the FDA appropriations congressional subcommittees. While this effort is currently focused on lawmakers on the funding panels, Washington-based advocacy will commence for members of the new congressional supercommittee that will negotiate a deficit reduction plan for 2013 and beyond, according to an organizer of the lobbying activities.

A government watchdog who has actively targeted industry influence on FDA is now considering pressing the agency to be more active and vigilant to deem some ghostwritten medical journal articles as off-label promotion, although any agency action could meet legal challenges based on a decade-old lawsuit and the First Amendment, sources said. However, if FDA cannot curb ghostwriting, the court system could be leveraged against this type of research, according to an academic who has studied this issue.

A collaborative group from government, academia and the non-profit sector is pressing FDA to expand regulatory science on the development and evaluation of repurposed drugs for orphan diseases and evaluate the creation of a new approval path for rare blood cancer treatments.

FDA is prioritizing enhancing knowledge on personalized medicine, toxicology, consumer communication and food safety among its regulatory science goals, the agency says in a revised strategic plan released Wednesday (Aug. 17).

FDA will establish a center to study regulatory science under an agreement finalized Friday (Aug. 12) between the agency's National Center for Toxicological Research and the state of Arkansas, where the toxicological center is located. The agreement, which will establish the virtual Center of Excellence for Regulatory Science, is the first between the agency and a state to further regulatory science initiatives, according to FDA.

The Premier healthcare alliance is urging FDA to close manufacturing lines associated with violations as opposed to shuttering entire plants, and requesting the agency conduct quicker reinspections of closed drug manufacturing facilities to help curb the growing drug shortages crisis, which has garnered both federal and state-level attention. The ideas emerged as the hospital group released Tuesday (Aug. 16) a new analysis of unsolicited drug sales offers, illustrating an emerging market of medicines coming from an unofficial supply channel -- known as a gray market -- and have resulted in steep price increases and safety issues for pharmaceuticals in short supply.

A free speech group questioning the legality of the composition of a controversial Institute of Medicine panel that drafted a report on the 510(k) medical device clearance process said it is unlikely FDA will face legal action, even if the agency had pledged to consider the committee's recommendation to replace the 510(k) clearance process instead of dismissing the proposal, although FDA is facing pressure from various stakeholders to consider IOM's idea.

A rare disease advocacy group is lobbying FDA and preparing arguments for Congress on its plan to revamp the agency's pharmaceutical review structure by increasing user fees and creating more review specialties, saying the Prescription Drug User Fee Act reauthorization agreement, which includes provisions for rare diseases, does not do enough to bring changes for orphan drug review. The EveryLife Foundation for Rare Diseases recently pushed the idea in a meeting with FDA Commissioner Margaret Hamburg and plans to advocate for the concept on Capitol Hill as user fees are debated next year.

Fiscal hawk Sen. Tom Coburn (R-OK) is criticizing the Institute of Medicine study of the FDA 510(k) device clearance process as a "waste" of taxpayer dollars after the agency flatly rejected the group of experts' highly controversial recommendation to scrap the medical device review program. The 510(k) process assessment suggests a larger problem with IOM, which Coburn's office says has been disproportionally subsidized with more than $300 million in taxpayer funding over a ten year period.

A coalition of personalized medicine advocates have begun pitching possible reforms and incentives for the development of these products to key lawmakers for inclusion in genomics legislation, proposing to create an overarching FDA personalized medicine office, implement mandated review times for companion diagnostics, extend healthcare reform's research and development tax credits and expanded CMS coverage of personalized medicine products, according to a Capitol Hill proposal obtained by FDA Week.

Rep. Michael Burgess (R-TX), vice chair of the Energy and Commerce Subcommittee on Health and one of a handful of physicians in Congress, is using the deficit reduction debate to push for postponing implementation of the Affordable Care Act until the Supreme Court renders a decision on the law's constitutionality -- which it is widely expected to do eventually, especially after two federal appellate courts reached split rulings on the individual mandate. In an interview Tuesday afternoon (Aug. 16), Burgess said delaying the law's spending measures that begin 2014 would save money, though like other Republicans he would like total repeal of the law.

Proposed FDA guidance for designing high-quality clinical studies in support of medical device premarket approval applications could conflict with previous agency policy for sponsors to conduct the most appropriate trials that might not include a random, double-blind investigation, according to industry sources.

Researchers supported by National Institutes of Health funds created the first computer model that assesses genomic information and helps determine new uses for existing drugs, with the study emerging amid an FDA effort to repurpose marketed pharmaceuticals for rare diseases.