As medical product user fee negotiations begin to take shape, consumer and safety advocates are prioritizing the inclusion of comparative effectiveness information in the premarket and post-market settings that they say would make FDA the leader in this new aspect to the U.S. healthcare system. Comparative effectiveness research could factor into labeling decisions and help monitor the performance of Risk Evaluation and Mitigation Strategies through bolstered post-market surveillance, particularly by employing the Sentinel Initiative database to examine medical products' safety signals, sources said.

FDA is reluctant to support labeling for genetically engineered foods despite the drumbeat growing louder for notification to consumers, with the possibility increasing that the agency will hold public meetings on transgenic salmon this fall, according to informed sources closely following the issue. News that a Massachusetts-based company could be the first to bring genetically engineered food forward comes at the same time as the introduction of right-to-know labeling legislation in the House. Advocates of GE food labeling tell FDA Week that they are thus ramping up their lobbying efforts to prepare for the fight, including putting a focus on what it sees as the agency's hypocrisy regarding changes in smell, taste and texture.

Resolution of some outstanding issues in a California price-fixing pharmaceutical case could pave the way for the courts to address major underlying drug industry issues -- including pay-for-delay settlements and higher domestic prices for pharmaceuticals compared with their Canadian counterparts -- by stripping drug companies of a defense against these suits, sources said. The California Supreme Court decided Monday (July 12) in the case to reverse a lower court ruling that dismissed the suit based upon the pass-on defense, thereby forcing several large drug manufacturers to litigate the issue.

An FDA advisory committee vote to keep the diabetes drug Avandia on the market has not silenced concerned lawmakers and safety advocates urging for the product's withdrawal from pharmacies, with stakeholders still calling for a greater firewall between the approval and post-market safety offices in the agency's drug center, alongside bolstered FDA post-market monitoring authority added to upcoming drug user fee legislation. FDA's final decision on Avandia is expected to hew closely to the advisory panel's recommendation, with the agency's actions viewed as a seminal moment for the Obama administration's FDA that could possibly result in calls for leadership changes, sources said.

A group of high-profile safety advocates -- including a top FDA adviser -- is calling for a series of statutory and regulatory changes to the device review process, such as raising the approval bar to equate data standards for these products with requirements for drugs, while also severely limiting the viability of an expedited clearance pathway for novel products. The medical device industry fired back, saying that Congress recognizes that their products are substantially different than drugs, therefore requiring diverse review pathways that account for incremental and evolutionary changes to the device.

Ahead of this week's FDA advisory committee hearing on GlaxoSmithKlein's diabetes drug Avandia, a panel of healthcare experts urged the agency in a report released July 9 to only permit a post-market clinical trial that examines a drug's safety if FDA adheres to ethical considerations, including requiring that the study will appropriately resolve disputes on the pharmaceutical's risk-benefit profile and that patients receive adequate information to make an informed decision on their participation.

Supporters of a bill limiting antibiotic use in animal feed could obtain their first House Republican cosponsor for the hotly contested and controversial measure, a move that would boost the legislation's likelihood of passage. The measure could get roped into a broader antibiotics-related bill that is under consideration by lawmakers, although such a strategy has yet to be fully formalized, a top committee lawmaker told FDA Week.

Patent submissions for new drug applications have become increasingly complex and time-consuming, but FDA's estimate of the time-burden is being seen in the industry as appropriate and any pushback that the agency may have heard on the higher workload will likely not materialize, sources said.

Included in the House Education and Labor Committee's version of child nutrition legislation passed Thursday morning (July 15) is a requirement for the Department of Agriculture to review additive efficacy claims in its infant formula purchasing program and pass its conclusions along to FDA and other agencies. FDA has long rejected any role collecting data on efficacy of additives in infant formula or any other packaged food, and the new data could give the agency newfound room for its own evaluations, sources said.

Two top congressional investigators further fueled concerns about the diabetes drug Avandia ahead of the two-day FDA advisory committee meeting on the drug, calling into question clinical trial disclosure and ghostwriting practices of the pharmaceutical's manufacturer, GlaxoSmithKline, and the industry in general. The lawmakers' focus on these two issues highlights broader concerns with drug industry disclosure, including whether companies properly release all their trial data and disclose any influence in the development of research papers, a consumer advocate said.

Pharmaceutical industry leaders are pressing FDA officials to complete their work on new guidelines for clinical trials on antibiotics, telling agency leaders in Boston last month that the current decade-old guidelines are creating a culture of uncertainty and having a "very chilling effect" on investors, according to an industry attendee.

Food safety legislation continues to languish on the back burner, with some advocates holding diminished hopes that the full Senate will vote on the measure before the August recess or even at all during this Congress. Supporters of the legislation also criticized the White House for failing to press for Senate action with the same vigor used to pass other bills, but sources also noted that FDA has remained an active advocate for the measure.