FDA's proposed biosimilars user fee structure would charge sponsors of these new types of products the same as their innovator biologic reference drugs, with the agency suggesting that clinical trial fees -- not just completed application fees -- should be paid because these follow-on pharmaceuticals will likely require more agency input during that phase of the development process, according to an agency notice posted online Monday (May 9). The parity in biosimilars and innovator fees and review times could suggest that FDA will require comparable amounts of data, thereby disincentivizing the use of the health reform-created pathway, some sources said, with a brand-name drug industry official contending that fees should also be used for post-market monitoring, as is the case with innovator products.

The food industry is urging FDA to only mandate that firms collect information on the origins of their products from the immediate supplier, and not collect data from other elements of the supply chain as part of requirements in the new food safety law, with some stakeholders contending that applying traceback requirements to all elements of the supply chain could violate trade agreements and overlap with other mandated preventive controls, according to sources and comments filed to the agency. The European Commission suggests that its regulators could play a role in verifying European suppliers to avoid duplicative oversight.

FDA is seeking social media advice for its own communications practices as it crafts a much-anticipated guidance to govern the drug industry's utilization of Web 2.0 tools, with the agency struggling with how much its outreach efforts should include new Internet-based applications. The agency is mulling whether to take a more active role in social media outlets to interact with the public on issues like recalls and enforcement actions, but a former FDA communications official said the agency needs to embrace new media now to fulfill its public health mandate and to set an example for the industries it regulates.

The parameters for a likely generic drug user fee program include having a single stream of applications that would be reviewed on a first-in, first-reviewed basis, with firms also paying a separate fee for inspections, albeit that latter payment would only apply to generic manufacturers and not brand companies, contrary to some proposals previously advocated, FDA officials told stakeholders Tuesday (May 10).

FDA might not be legally allowed to utilize the Institute of Medicine's forthcoming report on the 510(k) device clearance process because the panel drafting the recommendations doesn't include key stakeholder representation, including industry, venture capitalists and patient advocates, according to an influential device industry attorney, who contends that FDA could address the issue by scrapping the report altogether or reconvening the panel with a broader array of stakeholders.

A founder of a new House caucus to promote utilization of generic pharmaceuticals said lifting the ban on drug reimportation could be explored in the group's efforts to encourage prescribing of lower-cost products, with Rep. Jo Ann Emerson (R-MO) citing the brand-name drug industry as the biggest challenge in getting legislation passed to allow importation of cheaper medicines from abroad. Emerson and Rep. Peter Welch (D-VT) Thursday (May 12) established the legislative caucus aimed at increasing the use of generic drugs to reduce health care costs.

An FDA official pushed back against some industry concerns that a forthcoming guidance on biosimilars will not be out in the near future or answer all the the outstanding questions with how the pathway will be structured, saying that several high-ranking agency officials have indicated that initial clarity from the agency will be out by year's end and will be substantive.

The Federal Trade Commission's competition office issued guidance letters this week to the drug industry outlining when firms must notify the agency on patent settlements as mandated by the Medicare Modernization Act, instead of fining three companies that had not submitted the necessary documentation.

GOP lawmakers are considering slashing the HHS appropriations and FDA-agriculture subcommittees' portion of the budget, with the House Appropriations Committee intending to hold markups on the fiscal 2012 FDA appropriations bill this month and consider the HHS funding measure later this summer, according to a schedule proposed by the top Republican on the panel Wednesday (May 11).

Some smaller generic pharmaceutical firms are already dissenting on the basic foundations of a generic drug user fee program, with at least one firm arguing that the program is wholly unnecessary and would add to the regulatory burden of getting a product through the agency. FDA counters, though, that it is continuing to seriously consider comments from stakeholders not present at closed-door meetings and is undergoing an administration-wide assessment of regulations to identify policies that place an undo burden on industry.

A top FDA policy official said this week that the agency is expecting Congress to wrap all the user fee programs -- including the non-existent generic drug and biosimilars efforts -- into a single legislative vehicle when lawmakers renegotiate brand-name pharmaceutical and medical device fees next year.

FDA's initial proposal for biosimilars user fee negotiations calls for participation in the FDA-industry meetings by trade associations and companies interested in developing these products, but the agency says it lacks a firm grasp on which groups will participate because these cheaper biologic products do not exist yet in the United States.

The medical device industry and a bipartisan group of lawmakers are continuing to raise concerns about a lack of industry and patient representation in the Institute of Medicine committee tasked with assessing reforms to the 510(k) device clearance process, with some key Capitol Hill players weighing ways to ensure certain unrepresented parties -- including venture capitalists -- are given an opportunity to provide input.

California's general assembly is rapidly advancing legislation to mandate labeling of genetically engineered salmon, with the measure's possible passage likely to have a major impact on how FDA moves forward because the state has a massive market and could set the first standard for warnings on these products, food safety advocates contend.

The National Institutes of Health chief told lawmakers Wednesday (May 11) that the research hub could play a role in ensuring royalty sharing with the drugs it helps develop, but said there is little the agency could do to interfere with steep drug costs, noting that previous efforts to add pricing clauses to NIH contracts failed in the 1990s. Sen. Sherrod Brown (D-OH) raised the issue in the context of NIH's role in developing the pre-term labor drug Makena during a Senate appropriations hearing and asked how to avoid similar issues with taxpayer-funded research.

The tobacco industry is pushing for a spectrum of modified risk claims for its products, citing concerns that previous products with drastically reduced risk did not fare well in the market and different levels of modified tobacco could ween smokers off the habit. Meanwhile, toxicology experts Monday (May 9) urged an Institute of Medicine panel charged with developing scientific standards to recommend clinical trials for tobacco health claims.

The National Research Council recommends that FDA expand the way it assesses risk in its decisions through a specific framework -- whether during product approvals, withdrawals or recalls -- beyond examining morbidity and mortality rates to also consider the number of people directly impacted, how affected individuals can control or reduce risks through other methods and the ability to detect or mitigate adverse health effects. The recommendations in the report -- which was conducted at the request of FDA and released Monday (May 9) -- would not replace existing agency procedures, but instead complement them.

Public Citizen says there are omissions of data in an Alzheimer's study published in the Journal of the American Medical Association, saying physician interpretations of brain scans using an experimental positron emission tomography injection varied according to data submitted to FDA, but the study's authors only included median measurements in the JAMA study, garnering misleading conclusions about the injection, florbetapir F 18.

The use of comparative effectiveness research for choosing treatment may take on a lower political profile if accountable care organizations catch on, sources say. CER naysayers say the research is a way for the government to ration care and get between patients and their physicians, but if physicians in ACOs use the research to find appropriate treatments for their patients, instead of CMS using the research for coverage and payment decisions, the debate over the CER may cool, sources say.

The absence of special General Services Administration appropriations for FDA consolidation on the White Oak campus might hamper the agency's bioterrorism efforts, sparking concerns from Maryland lawmakers who are urging the government administrator of buildings to devote specific funding to construction on the facilities and prompting FDA to discuss the issue with GSA.