Consumer and safety advocates are complaining that the user fee agreement negotiated between FDA and industry doesn't commit to scaling-up the post-market safety Sentinel program or using the system to look at effectiveness and non-predictable events, adding that the drug safety monitoring program is not living up to what was envisioned when it was crafted by Congress as part of the FDA Amendments Act in 2007.

Orphan drug advocates are continuing to push their own policies -- including through filing a citizen petition calling for FDA reviewer flexibility -- while also voicing support for provisions in the recently released drug user fee agreement. The agency-industry pact calls for policy development and staffing increases to address rare diseases, but FDA could take years to tackle topics like non-traditional clinical development programs, reviewer flexibility, and challenges with post-market studies, sources said.

The Senate appropriations panel is urging FDA to share information with CMS on whether drug trials involve placebos or active controls and whether study designs mandate superiority beyond an existing treatment or a placebo, with the request approved as part of the FDA-Agriculture appropriations report cleared out of committee late Wednesday (Sept. 7). The report also includes language instructing FDA to submit its fiscal 2013 budget request with the same account structure as fiscal 2012, potentially highlighting an issue that some sources have said could arise given discussions as part of biosimilars user fee talks to encourage congressional appropriations specifically for this healthcare reform-created pathway.

The Senate appropriations panel cleared the fiscal 2012 FDA budget bill late Wednesday (Sept. 7) to boost FDA funding by $50 million beyond this year's level, with the bulk of the additional money targeting implementation of the new food safety law and leaving the medical product portfolio with nominal changes ahead of user fee negotiations next year.

An FDA stakeholder coalition lobbying for increased agency funding launched a Capitol Hill advertising campaign to stress FDA's role in regulating more than 20 percent of domestic consumer spending, while also helping the food, drug and medical device industries foster job growth and increase American competitiveness. The advertisements ran in several Capitol Hill publications on Tuesday and Wednesday (Sept. 6 and 7), as the Senate appropriations panel passed the agency spending bill, slightly boosting agency funds (see related story).

The final day of Senate floor debate on patent reform legislation centered on a controversial provision to extend patent terms, potentially resolving a decade of court challenges and past attempts by lawmakers to give legislative clarity on this issue. Senators rejected 47-51 an effort to remove House-passed language that offers some leeway in patent extension filing deadlines, most notably affecting Medicines Company, which missed a deadline in 2001 for its anti-coagulant Angiomax. The overall bill cleared the Senate Thursday (Sept. 8) evening, with the legislation now on its way to the White House for President Obama's signature.

The Generic Pharmaceutical Association selected Ralph Neas -- a health system reform advocate, opponent of conservative judicial appointees and failed congressional candidate -- as the follow-on medicine trade lobby's next president, effective Sept. 12. FDA Week first reported the move Tuesday (Sept. 6) ahead of the Wednesday (Sept. 7) announcement.

The House Energy and Commerce Committee is prioritizing changes to FDA's medical device and drug regulatory approaches as part of the fall 2011 agenda ahead of user fee reauthorizations next year, with the panel also setting its sights on both tackling healthcare reform's grandfathering regulations and options to alter the Medicare physician payment formula, the Republican leadership of the committee said Tuesday (Sept. 6) as Congress returned from the summer recess.

FDA plans to hold a public meeting in the "next couple of months" on the drug user fee reauthorization pact released last week and then make any revisions as necessary, an agency official reaffirmed. That process, the official said, would be completed in time for the agency to submit a final package to Congress in January of next year. The user fee package -- negotiated with industry -- is expected to become a vehicle for various FDA reforms, including possibly drug safety legislation.

Proponents of limiting antibiotic use in animals ramped up their Capitol Hill lobbying to counter assertions that restricting utilization of these drugs to prevent disease would not be based on "hard science," reigniting a debate from earlier this year after Republicans initially attempted to pass appropriations language governing FDA decisions in this area. An opponent of the limits, though, countered some of the assertions as not portraying the entire picture of evidence, as Senate appropriators also press FDA to more rapidly finalize its policy.

The medical device industry is heralding a new study released Wednesday (Sept. 7) on the healthcare reform law's $20 billion device excise tax as fodder to oppose the fee, with the report's authors arguing that the tax will push device firms overseas and result in up to 43,000 job losses during stagnant economic times.

FDA needs to work with experts and heed advice from the Institute of Medicine in crafting guidance for using meta-analysis in its regulatory review process, safety advocates and a meta-analysis expert said following the release of the agency-industry negotiated Prescription Drug User Fee Act agreement that includes measures for developing a dedicated meta-analysis review team and a guidance document on the agency's approach to reviewing these large studies.

The Federal Trade Commission for the first time has brought a case against marketers of smartphone applications for making baseless health claims, a move that emerges amid FDA establishing a policy on how it will assess these products and their claims. The settlement with the firms has been approved by FTC but not finalized.

FDA officials said Wednesday (Sept. 7) that they will not endorse specific technology as they proceed with fulfilling product traceback requirements mandated by the food safety law, but instead identify overarching elements of a product tracing system. The Institute of Food Technologists, a Chicago-based not-for-profit scientific society, will conduct two pilot projects to inform recordkeeping regulations for high-risk foods as required by the new law.

The advocacy organization Public Citizen is adding its voice to a growing chorus of stakeholders calling for FDA to consider the Institute of Medicine's controversial recommendation to scrap the 510(k) medical device clearance process, with the group saying Friday (Sept. 2) that the agency is "kowtowing" to industry and criticizing FDA leadership for dismissing the prominent research hub's proposal issued in July.

FDA medical device reviewers will complete up to 18 months of certification and visit manufacturers, research organizations, academic institutions and healthcare facilities as part of two new training programs intended to improve the consistency of reviews and implement a core tenet of FDA's proposals to improve the 510(k) device clearance process, the agency said Tuesday (Sept. 6).

Sen. Michael Bennet (D-CO) is voicing support for and urging FDA to back a federal pedigree system in light of the growing drug shortages epidemic and an increasingly utilized illegitimate medication supply chain. Establishing a national pharmaceutical tracking system could be incorporated in major legislation in the works by Bennet and is the latest in a long line of suggestions --including drug reimportation and different approaches to facility reinspections -- floated by stakeholders and lawmakers to mitigate drug shortages.

Two key congressional panels are preparing hearings on the drug supply chain ahead of the pharmaceutical user fee debate next year, with the Senate health committee planning to convene Sept. 14 to hear testimony from FDA, industry and Congress' investigative arm. Meanwhile, the House Energy and Commerce Committee is also tentatively planning to hold a hearing on drug shortages, but the panel has not formally scheduled or announced its plans, according to an informed source. Other sources say the hearing is tentatively scheduled for Sept. 23. FDA will also hold a public workshop on drug shortages Sept. 26.

FDA is reviewing whether new product identification technologies can be utilized, potentially signaling changes to medical product distribution policies and fostering some concern that FDA could prescribe use of different technologies. FDA's action, as part of a broader regulatory review process, coincides with its decision to allow vaccine manufacturers to request an exception from bar code label requirements, although the move is not expected to substantially alter larger distribution practices, according to supply chain stakeholders.

The FDA-industry agreement to utilize drug user fees to expand the agency's capacity for evaluating patient-reported outcomes (PROs) and other endpoint assessment tools signals that the qualification process for these instruments is becoming institutionalized and could expedite efforts to develop standardized instruments and encourage growth of companies that develop these tools, according to industry sources. A patient advocate said development of PROs could help make the clinical trial process faster and more efficient, leading to better treatments for rare diseases.

Without monograph modernization efforts currently underway, outdated safety standards could lead to the demise of the over-the-counter drug system, FDA's top pharmaceutical official warned Thursday (Sept. 8) as the agency continues its work with the U.S. Pharmacopeia and industry to add components like identity and impurity tests to monographs. During a USP workshop on the subject, FDA officials cited challenges with the monograph system, including the ability to make changes to include universal quality standards for manufacturers.