Lawmakers are expected to soon address the growing threat of drug diversion, but the various bills under consideration are not expected to be weighed as an omnibus measure and will instead be reviewed by different Senate panels due to jurisdictional hurdles. The issue will be addressed in a Senate Judiciary Committee hearing next week and one of the measures, introduced by Chuck Schumer (D-NY), is expected to be considered as a standalone bill by the committee, unlike other FDA-centric measures that will be assessed by the health panel.

A prominent academic at the forefront of comparative effectiveness research pharmaceutical detailing efforts will soon begin seeking support for the establishment of a third-party payer non-profit organization to help physicians receive information on medical therapies from a wider group of experts -- including insurance companies -- as opposed to predominantly from drug manufacturers. The concept could still face the criticisms of traditional academic detailing programs, where the drug industry contends that it is held to different standards and has only its speech restricted.

Senate aides are investigating findings and weighing next steps after a government contractor drafted a report on administrative controls and procedures for staff selection in FDA's device center, after the staffers were allowed to view the report, which has been kept under close wraps by the agency, according to an FDA letter, an informed source and documents obtained by FDA Week via a Freedom of Information Act request.

Foreign stakeholders are watching how FDA's new import policies translate at the borders and how the agency considers the nuances of foreign food systems, including decentralized food oversight and utilization of harmonized third-party benchmarking and audit systems. The European Union is pushing for exceptions to mandated FDA audits as allowed by the new food safety law, with stakeholders making the case directly to FDA in closed-door meetings that the European system is highly developed and explaining its different qualities.

The Supreme Court's refusal to hear a case assessing whether a second patent on a drug for a new indication constitutes "double patenting," allowing a circuit court's ruling dismissing the additional patent to stand, with that outcome possibly disincentivizing companies from conducting follow-up research on their products on off-label or rare disease indications, according to sources. The high court's reluctance to hear the case could stem from statutory revisions to the patent code that reduce the likelihood of similar patent situations occurring in the future.

The board of the health reform-created comparative effectiveness research hub selected the group's first director who hails from a major payer, with the announcement Monday (May 16) sparking concerns from several medical product industry sources that this new institution could shift its mission toward rationing care and cost effectiveness, as previously feared by many Republicans on Capitol Hill. However, the selection was also defended because of the breadth of experience of the organization's new director, who has directed hundreds of research staff at a premier CER-utilizing institution.

A key GOP lawmaker central to the reauthorization of HHS' medical countermeasure development effort intends to examine how Congress could amend the emergency use authorization process this session, suggesting that responsibility for activating this tool to provide patient access to unapproved medical products should perhaps move out of the White House and to HHS. The assessment of the EUA process -- which an influential Democrat on the panel said should be considered -- could take root in the reauthorization of the Pandemic and All-Hazards Preparedness Act, with HHS' top preparedness chief also brainstorming methods to amend the emergency authority.

Sen. Herb Kohl's (D-WI) plan to retire after the 2012 elections could either fuel passage of his bill to curb drug patent settlements or end the years-long legislative battle to limit these agreements, sources said. Passage of the legislation remains a high priority for Kohl, as drug industry officials said they are bracing for a potential last-ditch push to pass the bill, which they oppose.

The applicability of small business exemptions in the new food safety law to foreign producers within close proximity to the U.S. border is raising questions among stakeholders, who are pressing FDA to define how these provisions will affect the statute's importer elements, like supplier verification, sources said. An industry attorney, however, said the impact of the law on small businesses is not nearly as integral to the market as the forthcoming third-party accreditation standards that will impact larger wholesalers.

Findings from a recent Government Accountability Office audit of seafood import oversight that cited deficiencies in sampling and collaboration could guide FDA's implementation of the new food safety law's foreign supplier verification program and prevention elements, which largely mirror the seafood Hazard Analysis and Critical Control Point system's structure. Meanwhile, a key Democratic lawmaker and industry source also pointed to the study as an argument for increased agency resources and collaboration among government agencies.

A coalition of mobile health technology stakeholders is proposing FDA regulate mHealth accessory products akin to the way the agency previously said it would oversee them for medical device data systems, with the group also contending that the de novo review process for novel devices could play a significant role in regulating these emerging products.

A top Senate Democrat is urging FDA to clarify the difference between dietary supplements and foods containing additives in the wake of news reports that brownies laced with the naturally occurring sleep aid melatonin are marketed as supplements -- not food with additives -- and causing hospitalizations. While FDA has not specifically addressed this issue in regulations, the agency has provided clarity to firms through letters, presentations and a guidance distinguishing between liquid supplements and traditional beverages, with the agency saying that dietary supplements cannot be marketed in food form, sources said.

FDA is floating a three-pronged plan as part of device user fee negotiations under which it would develop criteria for its application "refuse to accept" policy, only start the review clock for 510(k) and premarket approval submissions once the agency receives a complete application, and convert investigational device exemptions to pre-IDEs if applications are "grossly incompetent." The proposals, designed to target agency resources by reviewing only complete device applications, might strike the ire of industry because there are concerns the agency could refuse to accept applications as a way to avoid failing to meet certain performance goals, industry sources said.