A day before FDA was slated to discuss its compounding plan with states, Public Citizen called on HHS Secretary Kathleen Sebelius to reject FDA's proposal and instead embrace an alternative crafted by the public interest group. Public Citizen lambasted FDA's plan as well as FDA Commissioner Margaret Hamburg's performance during recent congressional hearings. The group wrote to Sebelius that FDA's plan to create a tiered oversight system of traditional and non-traditional drug compounding would instead create "a legal gray zone" and allow substandard drug manufacturing.712 words

The House on Wednesday (Dec. 19) passed a bill forged by House and Senate leaders to reauthorize HHS medical countermeasure programs, but the compromise legislation, which has the support of Senate health committee leadership, could face opposition from some members in the upper chamber because it fails to include a White House-backed strategic investor program or a federal drug track and trace system.859 words

Stakeholders are questioning how FDA, in the face of possible sequestration and the fiscal cliff, will be able to meet inspection requirements under both the FDA Safety and Innovation Act and the Food Safety Modernization Act, and a former FDA official said the food law's mandate for a specific number of prevention-based inspections every two years could lead to fewer drug inspections, which Congress requires FDA do only when there is a perceived risk. But an FDA funding advocate said FSMA inspections quotas instead send a message to appropriators that the agency needs further resources to maintain safety and efficacy standards for all its regulated industries.900 words

Jane Axelrad will step down from her post as head of the Office of Regulatory Policy in FDA's drug center early next year to take the lead on issues related to pharmacy compounding in the wake of a deadly meningitis outbreak, according to a memo drug center chief Janet Woodcock sent to FDA staff. The announcement comes as FDA convenes a meeting with state regulators on pharmacy compounding Wednesday, and the agency, stakeholders and lawmakers continue to debate possible policy changes to address gaps in compounding oversight.424 words

The staff of FDA Week would like to wish you a joyous holiday season and a happy, healthy New Year. In observance of the holidays, FDA Week will not be published on Dec. 28. Your next issue will be dated Jan. 4, 2013.46 words

FDA's recent guidance for using clinical trial enrichment -- selecting patients based on characteristics that could enhance the detection of a drug's effect -- outlines strategies that have the potential to ease the time and cost of drug development, a top FDA official said. Advocacy groups said the document builds on other personalized medicine guidance documents, taps into the potential for drugs geared toward patient subgroups and outlines various scenarios for incorporating biomarker negative patients into studies.659 words

Those wanting FDA to adopt stronger drug diversion policies for opioids are urging lawmakers to quickly pass legislation that would mandate such policies because of concerns FDA will not act on the issue before non tamper-resistant generic painkillers come to the market in January. As the advocates turn their focus toward legislation, several lawmakers, including Sen. Tom Coburn (R-OK), continue to press FDA to administratively require generic painkillers be tamper-resistant before they receive approval, with congressional sources skeptical Congress will pass legislation on the issue before the lame duck session ends.1033 words

Producer groups said the animal drug user fee reauthorization should not become a vehicle for changes to postmarket antibiotic requirements, as public health groups grow increasingly frustrated that their suggestions for increased antibiotic data reporting were not addressed through the user fee negotiation process. Industry insists that data reporting proposals should be taken up outside the Animal Drug User Fee reauthorization.1008 words

A group representing antimicrobial drug developers urged FDA to retain a "high degree" of flexibility in assessing which products will qualify for antibiotic development incentives in the recently enacted FDA Safety and Innovation Act, and establish a broad and inclusive list of pathogens that qualify for the new designation to attract companies and investors into the antibiotic space. A consumer advocate, however, urged FDA to focus on pathogens that cause mortality and morbidity in patients, saying the Generating Antibiotic Incentives Now provision will fail to improve public health unless there is a focus on patient-centered outcomes.898 words

In a win for the imaging industry, CMS on Thursday (Dec. 13) reversed its policy of not covering new positron emission tomography (PET) by proposing to let local Medicare Administrative Contractors decide whether to cover PET that uses radiopharmaceuticals for cancer imaging. However, it's not yet clear what the 15 MACs will do.315 words

Medical device trade groups released surveys this week highlighting the cost of implementing the health reform law's device tax as they work to push for congressional action to delay and ultimately repeal the $30 billion tax. A group representing medical imaging and radiation therapy manufacturers says 40 percent of its members who responded to a survey said they will cut their workforce if the tax kicks in Jan. 1 while the Advanced Medical Technology Association says 62 percent of members they surveyed say they are planning layoffs or reductions in hiring to offset the tax.502 words

Amgen agreed to pay $762 million to settle charges that it illegally promoted several drugs off label, inaccurately reported drug prices and paid kickbacks to health care professionals, according to the U.S. Department of Justice. "The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history," the DOJ release states.165 words

On Tuesday (Dec.18) the Patient-Centered Outcomes Research Institute approved 25 awards, totaling $40.7 million over three years, to fund patient-centered comparative clinical effectiveness research projects under the first four areas of its national priorities for research and research agenda.232 words

The Patient-Centered Outcomes Research Institute launched the PCORI Challenge, a competition to create a system that will connect healthcare researchers and patient partners in an effort to advance patient-centered comparative effectiveness research. PCORI partnered with Health 2.0, a San Francisco-based health technology company, to create the competition, which will award a total of $50,000 to winning developers, PCORI announced Friday (Dec. 14).222 words

David Vladeck, director of the Federal Trade Commission's Consumer Protection Bureau, is stepping down at the end of the year, and the bureau's deputy director, Charles Harwood, will serve as acting director, the commission said.220 words

FDA is working with the Environmental Protection Agency and other agencies to determine whether levels of arsenic in rice pose risks to human health and whether its presence stems in part from historic use of arsenical pesticides on southeastern fields once used for cotton production. FDA initiated the review this fall after Consumer Reports magazine drew attention to the levels of arsenic in rice.1885 words

A working group mandated by the FDA Safety and Innovation Act to outline, in the coming months, best practices for communicating drug labeling information to blind or visually impaired patients will hold its first meeting next month. The group -- which includes key pharmacy groups, advocates and drug store chains -- has already floated recommendations ranging from the use of audio devices to font and spacing suggestions.768 words

Medical gas manufacturers will have until July to comply with a new certification process mandated by the recently enacted FDA Safety and Innovation Act and can resubmit rejected certification requests within one month without penalty, according to a draft guidance document outlining the new medical gas certification process. Drawing from a proposal floated by the medical gas industry earlier this year, FDA said only entities that introduce certain medical gases into interstate commerce or produce the gas will be required to request a certification.659 words

A few drug companies are interested in new private pay models in which either plans or hospitals would pay licensing fees for antibiotics that are not connected with the volume of the antibiotics used, which would give drug companies a way to make money off of new antibiotics without overusing them, said Robert Guidos, vice president of public policy at the Infectious Diseases Society of America. CMS Medicare chief Jonathan Blum said he had not heard of such a pay model but he described it as "intriguing," and Guidos hopes to set up a meeting between CMS and a few drug companies to explore the idea.498 words

Premier healthcare alliance is pressuring FDA to start using a program devised by the generic drug industry to help mitigate drug shortages, and one source says there are signs FDA is moving forward with the program, despite earlier indications that enthusiasm was waning. The program -- the Accelerated Recovery Initiative -- will share manufacturing information about drugs in shortages with FDA through a third party and could be up and running early next year, according to a Generic Pharmaceutical Association official.846 words