FDA's device center has been staffing up as agreed to through the medical device user fee reauthorization even though fee increases have not come to fruition under the government's current funding measures, FDA's top device official recently said. Advanced Medical Technology Association officials said they are hopeful the agency's ability to fully collect user fees will be dealt with in an omnibus spending bill, but remain concerned about the effect of sequestration, which would hit the user fee program.608 words

Drug firms coming up to speed with FDA guidance on responding to unsolicited requests for off-label information are encountering questions as they get into the details of how the new programs, which focus on answering these questions privately, will work, said one company compliance officer who is trying to apply the guide to the company's promotional speaker programs, medical information websites and social media policies. The source said the company is grappling with how to train speakers to recognize on-label and off-label questions, and with the specifics of what FDA considers an off-label information request.861 words

Opponents of reverse patent settlements -- including a generic drug company, a group of professors and the House author of the generic drug statute -- argue in a slew of briefs filed with the Supreme Court that these deals allow weak patents to go forward, discourage challenges to patents and are incompatible with Congress' intent in enacting the Hatch-Waxman law. The briefs support the Federal Trade Commission's challenge of a so-called "pay for delay" agreement, joining other major players, including AARP, American Medical Association, America's Health Insurance Plans and a majority of states, that have also sided with FTC.1293 words

FDA is exploring cost-containment solutions such as using remote work plans, evaluating contracts to reduce duplication and leveraging expertise through various consortia, FDA Commissioner Margaret Hamburg told agency funding advocates this week. The strategies emerge in a tight fiscal climate that includes a continued standoff this week between President Barack Obama and Congress over the looming threat of sequestration set to take effect in less than a month. The across-the-board cuts could reduce food inspections by 2,100 in the next year, Hamburg said, offering a "ballpark" estimate intended to illustrate the effect of sequestration.497 words

Infectious disease experts are pushing back against the idea of using penalties to rein in off-label use of products approved through a proposed limited population expedited pathway, as stakeholders continue to grapple with how to monitor and ensure products approved for a small population of patients are not inappropriately used in broader groups of patients. A recent FDA meeting addressing how to set up a new pathway drew interest from a broad swath of patient advocates beyond the infectious disease community, but the Biotechnology Industry Association questioned if such a pathway would be voluntary and reiterated longstanding concerns about how it could impact the practice of medicine.952 words

Concerns about how provisions of the food safety law will impact small and midsize companies are resurfacing as FDA begins releasing the first proposed rules required by the law. A former director of FDA's center for food safety said requirements that companies hire food safety experts to develop food safety plans and take on responsibility to verify the safety of imported ingredients could place smaller companies at a disadvantage as they compete with larger businesses for resources.891 words

A major medical device industry trade group is working to enact state measures to counterbalance controversial federal tax and reimbursement policies, including seeking state tax credits to offset costs facing industry from the health reform-created medical device tax and FDA medical device user fees. The medical device industry also hopes to enlist state support for its continued lobby at the federal level to repeal the 2.3 percent medical device tax, with bipartisan federal legislation repealing the measure expected to be reintroduced in the House and Senate.968 words

FDA denied one of two citizen petitions filed by Endo Pharmaceuticals' requesting generic versions of its abuse deterrent Opana be similarly crush resistant, as the agency faces continued pressure from lawmakers to apply abuse-deterrent requirements to generic drugs. The agency's top drug official said FDA needs more time to determine if approval or disapproval of generic applications should be based on abuse deterrence.439 words

A coalition of pharmacy and patient groups is urging FDA not to follow an advisory committee recommendation to reschedule hydrocodone, saying there is no evidence the drug's abuse will decrease once the product is moved from Schedule III to the more restrictive Schedule III and that prescribers' "misunderstanding" of Drug Enforcement Administration regulations could further limit patient access to the products.379 words

FDA's final rule amending the agency's authority to administratively detain food, issued Monday (Feb. 4), is unchanged from an earlier proposal. The rule implements a Food Safety Modernization Act provision changing the criteria under which FDA can detain products it believes are adulterated and misbranded, voiding the requirement for the agency to present evidence that the food poses a health threat.262 words

House Energy and Commerce Committee GOP lawmakers warned FDA Friday (Feb. 1) to expect a subpoena if the agency doesn't hand over internal documents related to the deadly meningitis outbreak by Feb. 25. The GOP lawmakers have made repeated requests for the documents and set a final Feb. 25 deadline in a letter to FDA Commissioner Margaret Hamburg.369 words

The Generic Pharmaceutical Association Feb. 1 touted a report outlining the market possibilities for biosimilars, as patents for brand biologics with nearly $40 billion in annual sales in the United States will expire in the next four years. The industry group's assertion comes as brand companies ramp up state lobbying efforts for biosimilar substitution bills.202 words

Following months of pressure to release the health reform law's long-delayed physician-payment disclosure final rule, the Obama administration on Feb. 1 unveiled a final regulation that gives companies until August to start collecting data, allows physicians additional time to make corrections to information and limits reporting requirements for accredited continuing medical education. The release of the long-awaited final rule implementing the Physician Payments Sunshine Act drew praise from stakeholders, and a key lawmaker said he will closely watch the rule's implementation given the delays that have already occurred.1316 words

Arkansas Sen. Mark Pryor (D) said he will focus on funding for FDA's National Center for Toxicological Research, which is located in the lawmaker's home state, as he takes over as chair of the appropriations subcommittee with jurisdiction over the FDA's funding. The move could also draw attention to the agency's nanotechnology activities. Pryor's position, coupled with Maryland Sen. Barbara Mikulski's (D) ascension to the top spot on the full committee, means lawmakers with FDA facilities in their states will be in key spots, an FDA funding advocate pointed out.408 words

A drug company focused on antibiotic development is floating a profit incentive program for limited population antibiotics developed under the much-debated proposed approval mechanism, with the program ensuring company profits for five years in exchange for limits on drug promotion and off-label reimbursement. The incentive program would rely on the eligibility criteria developed for other antibiotic incentives outlined in the FDA Safety and Innovation Act, allow CMS reimbursement only for on-label use and require that hospitals develop HHS-approved stewardship programs to be eligible for reimbursement, said Rempex Pharmaceuticals President Daniel Burgess, who outlined the idea during a recent event held by Pew Charitable Trusts.803 words

Seven innovator drug companies are joining forces to analyze policies surrounding antibiotic drug development, including a limited population antibiotic approval mechanism and financial issues like reimbursement challenges with CMS and other payors.414 words

FDA will hold two additional public meetings on proposed produce safety and preventive controls -- March 11-12 in Chicago, IL and March 27-28 in Portland, OR. These are in addition to a Feb. 28 public meeting in Washington, DC. Stakeholders attending the meetings will be able to comment and ask questions about the proposed rules.138 words

The Senate Budget Committee will hold its first two hearings of the 113th Congress next Tuesday (Feb. 12) and Wednesday (Feb. 13) to review the Congressional Budget Office's newly released Budget and Economic Outlook report and the public's budget priorities.139 words

Drug development programs that include pre-investigational new drug meetings were approved more than three years faster than those without the early-stage meeting, according to a recent FDA analysis of new drugs approved between 2010 and 2012.292 words

House lawmakers will probe FDA and the broader federal government's reaction to the current influenza season at a Feb. 13 Energy and Commerce oversight subcommittee hearing that will also address the roles of manufacturers of vaccines and antivirals.143 words

President Barack Obama's call Tuesday (Feb. 5) for Congress to temporarily delay the budget sequester set to kick in next month by passing a mini-package of spending cuts and revenue raisers is scant on specifics, but the president suggested the plan draw from the fiscal cliff offer he put on the table in December which included $400 billion in health care savings without shifting costs to beneficiaries -- though the White House last week said the Medicaid cuts floated earlier are now off limits. The president left it to Congress to decide how long to delay the sequester, but said he hopes to put off any cuts for "a few months" until a federal budget can be worked out that permanently lifts the threat.921 words

FDA is proposing to turn the data obtained through its Mini-Sentinel pilot program into a national resource that could be used for health care research in addition to safety surveillance, and supported through a cooperative agreement between FDA and stakeholders. The agency's proposal to create a national data infrastructure, which would be complemented by independent centers to analyze the data and a cooperative agreement to refine the tools used, comes as FDA prepares to move into the next phase of the Sentinel Initiative and decides how to sustain the resource with the expiration of the Mini-Sentinel contract next year.886 words