Drug maker Allergan's decision to settle a years-long investigation into its off-label promotion of the popular medication Botox instead of pursuing its First Amendment lawsuit against FDA extinguished hopes from the pharmaceutical industry that resolution of the case would provide manufacturers with greater clarity on permitted discussions of unapproved uses. Without a court ruling in the case, drug makers may not obtain clarity for years, sources said, although the government's findings in the investigation offer some indication to pharmaceutical manufacturers of practices to avoid.

FDA is weighing how much pre-review oversight it should exercise over the single drug patient information documents it envisions for the future, with some stakeholders floating a tiered approach under which the agency would use its limited resources to review only documents involving high-risk products. How FDA resolves the issue, which is the subject of an upcoming agency meeting with stakeholders, has legal implications, as patient information documents not pre-reviewed by the agency could still trigger liability over their handling of risk information and generic labeling preemption, among other issues, sources said.

As FDA moves forward in assessing for the first time a genetically engineered animal for human consumption, a coalition of consumer groups, environmental associations and fisheries have expressed safety and environmental concerns with agency approval of the product, with a conumer advocate saying there is an inherent difference in these types of animals that require further study. FDA recently announced plans to hold meetings later this month to examine the safety and labeling of the genetically engineered fish, which is viewed as a template for future agency approvals of these types of products.

A key House lawmaker welcomed a new audit from Congress' investigative arm finding FDA continues to be cautious in the use of non-inferiority clinical drug trials to guide product approvals, although drug development sources warned that restrictions on these types of studies could stifle pharmaceutical development, particularly in the bare antibiotics pipeline.

As the Supreme Court prepares to examine whether medical product developers and life science firms must disclose all reported adverse events -- not only those situations with a confirmed link to a drug, device or dietary supplement -- to investors, a large swath of FDA-regulated industries are pressing the nation's top justices to reverse a lower court ruling that they say runs counter to a 1995 securities law aimed at reducing litigation. The high court is set to hear the case as early as December, sources said, adding that the hearing will focus on a homeopathic medicine, a quirk that could emerge and foster a ruling that would address only those types of therapies instead of all life science industries.

In order to accelerate private sector licensing of the government's biomedical inventions, FDA and the National Institutes of Health partnered with a government-wide website to streamline royalty payments by drug companies and other stakeholders, a prospect that sources said will ease collaboration between the public and private sectors while also speeding drug development. The program is expected to particularly affect smaller firms' commercialization efforts because the new initiative will lower costs, thereby maximizing those companies' limited resources, according to an industry source.

The Generic Pharmaceutical Association membership approved changes late last week to the group's governance structure that will provide larger firms with more clout, a move that could entice drug industry giant Teva to return to the organization and help provide a more unified industry voice as FDA moves forward on establishing generic drug user fees, according to several informed sources. Industry is preparing for generic drug user fee talks and FDA wants generic drug makers to speak with a single voice, sources said.

The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives outlined in an HHS report released last month, according to documents recently sent to Capitol Hill. Stakeholders say they are mixed about the proposal and would have preferred new funding devoted to the MCM initiatives, instead of using appropriations from one countermeasures program to pay for another.

A key Democratic lawmaker and some consumer advocates are raising concerns with FDA's communication to the public during the recent salmonella outbreak that prompted a massive egg recall. Some sources assert that the agency did not appear to follow draft recommendations on information disclosure, released a few months ago as part of the agency's transparency initiative. Meanwhile, FDA used the egg recall as an opportunity to push for passage of food safety legislation, which would provide the agency with increased authority.

This month's massive egg recall for salmonella contamination may create momentum for the much delayed Senate version of a bill aimed to improve safety of food products manufactured in and imported into the United States by giving FDA more power to call for mandatory recalls, increase facility inspections and better identify the source of the outbreak, according to food safety advocates.

Some proponents of animal antibiotic restrictions say FDA would need new legislative authority to use its Risk Evaluation and Mitigation Strategies authority to restrict certain classes of antimicrobials for veterinary purposes, an idea recently floated by the Infectious Diseases Society of America.

FDA's new agency-wide metrics program has improved accountability and will help track the implementation of new statutory authorities as the publicly accessible performance measurement system continues to aggregate more data, according to a top agency official. The system has been lauded by stakeholders as increasing transparency at the agency and ensuring FDA is held accountable for its spending, a particularly important effort due to potentially stagnant future appropriations, failed adherence to user fee goals and expected increases in responsibilities in food and drug safety.