The generic drug industry decided this week to drop its opposition to establishing a separate appropriations trigger that would enable FDA to utilize collected biosimilars user fee money, with that position crystallized after several phone calls, including with FDA Commissioner Margaret Hamburg, who guaranteed that the agency would find money to reach the biosimilars spending threshold, according to several informed sources. Members of the Generic Pharmaceutical Association held a conference call Wednesday (Aug. 24) morning to discuss the issue as negotiations on the healthcare reform biosimilars pathway commence, and a follow-up conversation with FDA is expected to take place soon.

A coalition of patient, consumer and public health advocates is bypassing FDA and directly asking HHS Secretary Kathleen Sebelius to include better monitoring of direct-to-consumer advertisements, an expansion of the Sentinel Initiative and greater flexibility in the Risk Evaluation and Mitigation Strategies program as part of the fifth authorization of the Prescription Drug User Fee Act, according to a letter obtained by FDA Week. The group argues that its ideas were dismissed with little debate during closed-door FDA-industry meetings, even though FDA faced new requirements during this PDUFA reauthorization cycle to include consumer and patient groups in the process.

FDA's recently issued guidance on developing products for neglected tropical diseases could lead to more use of a rarely utilized incentive program by increasing dialogue on the subject, with the document targeting new drug sponsors and affirming the ability to conduct clinical trials outside the United States, a stakeholder said. But a vaccine developer said more money is needed up front -- potentially by setting up a multinational research fund -- to encourage development of tropical disease drugs by not-for-profit organizations, which are taking the lead in this area and are working in developing countries to bring these medicines to market.

The dietary supplement industry is holding off on plans to lobby for legislation or seek legal solutions to address their concerns on a recently released new dietary ingredient guidance, discussing potential revisions to the document in a meeting last week with Sen. Orrin Hatch (R-UT), who is also outlining his concerns to FDA and pushing stakeholders to file comments on the policy, according to industry and congressional sources.

FDA recently buffeted dietary supplement firms' assertions that the agency is miscalculating the time it takes to file new dietary ingredient submissions, with an industry stakeholder saying the agency is not reflecting industry practices or anticipating the full impact of a landmark NDI guidance document. The issue arises as the recently released NDI guidance is expected to drastically increase the number of filings to the agency because of its stance on safety studies and grandfathered ingredients.

The Colorado bioscience industry this week urged top FDA officials and a key Democratic lawmaker engaged in the drafting of major medical product legislation to enhance predictability and consistency among agency reviewers, improve the device 510(k) process, and streamline product approvals to foster innovation and competitiveness.

Rep. Michael Burgess (R-TX) says White House regulations chief Cass Sunstein did not adequately provide a response to an inquiry on how FDA can better incorporate device industry input in the development of guidance documents. Sunstein defended FDA, arguing that both the administration's Office of Information and Regulatory Affairs and the agency have processes in place to ensure that the public can provide input in policy development, he says in a response to questions for the record from a recent Capitol Hill hearing.

Generic drug industry opposition to FDA's proposal to impose the same review times and fees for the healthcare reform-created biosimilars and the well established innovator product pathway is not a deal-breaker for these firms, which are now more concerned about the metrics of the program, according to sources and documents obtained by FDA Week that outline FDA's proposed benchmarks.

The National Institutes of Health updated its conflict of interest rules, now mandating that investigators disclose to institutions all financial interests related to their responsibilities, lowering the disclosure threshold from $10,000 to $5,000 and requiring institutions make significant financial interests for senior personnel accessible to the public. However, the policy, which was revised for the first time in years, has already garnered some criticism for not mandating public disclosure of conflicts of interests on a website.

Technology giant Google's $500 million settlement with the Department of Justice to offset profits from online Canadian pharmacies' illegal advertising to American consumers through the firm's search engine has resulted in a "fundamental transformation" of Internet pharmacy advertising practices, FDA's top criminal investigation official said Wednesday (Aug. 24).

Several sources have indicated that members of the Senate Appropriations Committee are likely to consider the FDA spending bill during Congress' first week back from the August recess through either a full panel or subcommittee mark-up, although a congressional aide declined to confirm whether debate on the measure would happen during the week of Sept. 5.

The White House's call to regulatory agencies to propose 5 and 10 percent cuts to their budgets for fiscal 2013 is unlikely to suggest major spending reductions for FDA given that the administration and HHS have regularly deemed FDA a priority and an exception to reductions. FDA would likely be shielded regardless of whether the cuts apply to HHS or the agency individually, an informed source said.

An Institute of Medicine panel found there are no links between vaccines and autism or Type 1 diabetes and rarely connections to other adverse events, information that could help assess claims in the Vaccine Injury Compensation Program and aid the government in awarding payouts to individuals injured by these drugs, according to a report released Thursday (Aug. 25).

FDA is reviewing applications to establish regulatory science centers in the Washington, D.C. area, executing a strategy outlined in a 2007 report and building on a joint initiative with Arkansas to create a virtual regulatory science hub, with the regional pilot project possibly expanding nationwide, a top FDA official said late last week.

FDA's fiscal 2012 budget is likely to be "in the range" of fiscal 2011 spending authority, FDA Commissioner Margaret Hamburg told the agency's science advisory panel Friday (Aug. 19). While lawmakers have cut many agencies in recent budget and appropriations bills, FDA obtained a slight increase in the fiscal 2011 spending measure, with informed sources suggesting the agency is well positioned for the coming fiscal year (see FDA Week, Aug. 12).

The Independent Specialty Pharmacy Coalition (ISPC), which represents community specialty pharmacies, asked the Federal Trade Commission on Aug. 22 to investigate Express Scripts' proposed acquisition of Medco. The coalition says the merger would lead to exclusive-distribution arrangements of the sort that it blames for the controversial price hike of the pre-term labor drug Makena.

Results of a new survey of large employees' health-benefit costs show that repealing the health insurance law would jumpstart the economy, Senate Finance ranking Republican Orrin Hatch (UT) said Thursday (Aug. 18), even though the survey found that the growth rate is falling slightly.

Physician advocates say they see an opening for medical malpractice reform in the super committee, but multiple health industry lobbyists foresee another dead end. Republicans have long sought medical malpractice reforms, and although Democrats may be skeptical, some have shown a willingness to compromise on tort reform, lobbyists say. The White House is eager to forge bipartisan consensus, but tort reform proponents fear there simply aren't enough votes in the Senate.

Both consumer and drug industry sources are calling for FDA to update and simplify guidelines for print advertisements in light of a recent study finding that marketing in medical journals generally did not adhere to FDA guidelines, with the new information backing a recent petition from medical product manufacturers' seeking clarity on off-label information dissemination rules.

FDA officials said Thursday (Aug. 25) that they agreed to a one-time generic drug backlog fee that would eliminate the queue in five years in part because it would give the agency immediate resources to hire personnel to implement a generic drug user fee program. The fee would give sponsors the opportunity to pull applications they do not intend to market, however an unpaid fee would not signify a withdrawn application, agency officials said, declining to give further details about the ramifications of not paying.