A highly anticipated FDA guidance on the health reform-created biosimilars pathway and clarity on some key outstanding issues might not emerge as "soon" as many stakeholders and potential sponsors would have hoped, as a top FDA biosimilars official signaled that many questions are still unresolved and declined to specify when a draft of the first document will be available to industry. The official also reinforced, though, that FDA has the authority not to mandate human trials if it so chooses, suggesting that the agency might specify when a biosimilar applicant does not have to show data from tests in humans in advance of formal guidance coming out, sources said.

FDA is proposing to tie mandated medical device postmarket studies with registries, and sources said the proposal may provide the agency with better control over the information collected after approving a high risk product, with the proposition emerging as part of FDA's draft proposals during medical device user fee reauthorization negotiations. The plan sparked a mixed reaction from industry, patient advocates and academics, some of whom questioned the quality of existing registries.

FDA's long-awaited social media guidance will likely be supplemented by findings from new internet studies that could resolve internal agency debate surrounding contentious issues or help the agency make a legal case for regulation, but the collection of information will further delay the process, sources said. The drug industry in particular has urged the agency to define marketing parameters for social media tools, like Twitter, Facebook and YouTube, with some companies delaying campaigns as they wait for direction from the agency, an industry attorney said.

FDA and industry have agreed on a prescription drug user fee proposal that would require reviewers to outline evidence, uncertainties, conclusions and reasoning behind assessing the risk and benefits of a drug, including describing the severity of a condition, unmet medical needs, clinical benefit and risk management for the medication, according to patient advocates and meeting documents. A patient advocate said he expected the reformed framework would lead to increased transparency in the process.

A possible appeal by Allergan in a failure-to-warn product liability case involving the company's widely prescribed Botox muscle relaxant drug could lead the plaintiffs to call for a reconsideration of state caps on the upper limit for payments from drug or device manufacturers to plaintiffs, lawyers on both sides of the issue said. However any argument on federal preemption grounds would not likely pass judicial scrutiny, industry attorneys said.

FDA rearranged its antimicrobial office to consolidate groupings by indication effective this week, but that restructuring might not remedy concerns from drug manufacturers that they are facing major hurdles in the approval process for antimicrobials, leading to a disincentive to develop these critically important pharmaceuticals, according to an agency memo and an antibiotics advocate.

The Federal Trade Commission's finding that the number of drug patent settlements increased by 60 percent last year suggests that brand-name and generic pharmaceutical firms are becoming increasingly emboldened to enter these pacts because both Congress and the courts have not banned these controversial agreements, sources said.

FDA is launching a new effort to ensure that reusable medical devices are free from debris and reduce the risk of communicating disease by updating guidance on best practices, holding a public meeting in June to solicit feedback and collaborating with two organizations to set standards.

A new study suggests that two drugs from the same company have equivalent safety and effectiveness for treating the same indication, despite the fact that one of the products is labeled for the usage and is substantially more expensive than the other pharmaceutical, which is used regularly off-label to treat the condition. The lack of labeling for the indication spurred calls from drug safety advocates for FDA to mandate comparative effectiveness studies ahead of approvals and require label statements stressing when a drug is not approved for a widely used indication, which could lead some firms to conduct the studies necessary to demonstrate safety and effectiveness for that usage.

A federal judge declined Monday (May 2) to decide whether FDA must enforce its own policy governing whether generic drug applications with fraudulent or inaccurate information should not be granted 180-day exclusivity periods, with the case already garnering substantial attention on Capitol Hill because the opposite ruling could have spurred an FDA decision on whether to allow generic versions of a multi-billion cholesterol lowering drug on the market within the next few months.

A federal appeals court's reversal of a ban on using National Institutes of Health funding for embryonic stem cell research will likely bolster researchers' ability to now assess these products that could result in medical breakthrough, as the court said in it's decision last Friday (April 29) that a long-used appropriations amendment preventing the destruction of embryos is "ambiguous."

The chain restaurant lobby is calling for more time to analyze FDA's proposed rule on menu labeling to enable industry to conduct consumer studies on different ways to meet the new requirements and how to display nutrition information, as mandated by the health reform law. While industry is calling for flexibility, including allowing several options to come into compliance, nutrition advocates have pushed for more detailed calorie declarations, especially for variable items like omelets, pizzas and burritos.

A new U.S. Department of Agriculture public-private market agreement to establish auditing standards for compliance with leafy green handling regulations might bolster or conflict with FDA's implementation of the new food safety law, particularly the development of federal produce handling standards. The new effort could amount to industry policing itself to monitor FDA guidelines or, conversely, assist FDA to enforce its forthcoming produce rules, sources said.

FDA has indicated it intends to evaluate its medical device third-party review program after finding quality problems with the assessments conducted by reviewers outside of FDA and amid concerns raised by safety and consumer advocates, who recently sent a letter expressing apprehension with the third-party review program, use of special government employees and any possible proposal to curb utilization of advisory committees, according to sources.

FDA is cracking down on a slew of products now available over-the-counter or online that make unproven claims that they treat, cure or prevent sexually transmitted diseases, with the agency now issuing warning letters and signaling the possibility of criminal action against firms that manufacture these products as well as the companies' executives. FDA has sent multiple warning letters to companies stating that such products -- which claim to treat herpes, chlamydia, genital warts, HIV and AIDS -- violate federal law because they have not been approved as safe and effective, FDA officials said on a conference call Tuesday (May 3) with reporters.

FDA on Wednesday (May 4) issued its first two rules under the new food safety law. The first allows the agency to detain food for up to 30 days that might have been produced under unsafe conditions, without needing to have credible evidence the food was contaminated or mislabeled. The second requires FDA to be notified if any food product imported into the U.S. has previously been refused entry by another country. Both take effect in early July.

Sen. Amy Klobuchar (D-MN), the chief congressional champion of legislation that would give FDA more authority to address drug shortages, urged Shire Pharmaceuticals to quickly remedy the dearth of its attention-deficit hyperactivity disorder medications, with the lawmaker leveraging the opportunity to bring attention to her bill.

FDA's top medical device official recently floated a proposal welcomed by some in industry that would allow for feasibility studies of mobile health technologies to be held earlier in the device development process for products that have been tested in real-world scenarios to ensure they are not detrimentally impacted by external technologies. The agency is also considering a mechanism that would allow product sponsors to unilaterally adjust trials to respond to findings on the technology.

The decision by the Office of the U.S. Trade Representative to attempt to table a complete proposal on intellectual property (IP) protections in the Trans-Pacific Partnership (TPP) negotiations by mid-June has triggered an intensified lobbying campaign by brand-name U.S. drug manufacturers that want to ensure the proposal reflects their interests.

The Pharmaceutical Research and Manufacturers of America is urging the Office of the U.S. Trade Representative to go beyond the Korea-U.S. free trade agreement (KORUS) and include 12 years of data protection for an emerging class of drugs that are derived from living organisms in a Trans-Pacific Partnership (TPP) final deal. A specific term of data exclusivity for biologics was established as part of health reform, and now U.S. drug companies want USTR to include that same 12-year period of data exclusivity in its forthcoming TPP proposal on intellectual property (IP) protections.

A Prescription Drug User Fee Act reauthorization compromise between FDA and industry to mandate the agency outline deficiencies in applications for new molecular entities and biologics by a late-cycle meeting indicates industry's efforts to give FDA a deadline to raise issues, but is not likely to prevent FDA from doing so after the meetings, according to an industry source and meeting documents. The move, the source said, could get FDA to consider issues such as requiring Risk Evaluation and Mitigation Strategies earlier in the drug review process, but consumer sources raised concerns that the discussions could lead to a weakening of Medication Guides, the most commonly used REMS measure.