The pharmaceutical industry is concerned that the administration's inclusion of FDA user fees among programs to be hit by the upcoming budget sequestration could permanently divert the industry-paid funding away from FDA, the head of the drug industry's trade group said Thursday (Sept. 20), a view echoed by the Biotechnology Industry Organization. The Pharmaceutical Research and Manufacturers of America, BIO and other industry stakeholders also worry that the mandatory across-the-board cuts could impede drug reviews and implementation of the recently enacted FDA Safety and Innovation Act, with PhRMA President and CEO John Castellani saying FDA would be unable to fill planned new industry-funded positions aimed at regulatory science, analytics and pharmacogenetics.696 words

The medical device industry may look to the lame duck session to pursue a fix allowing FDA to collect a higher level of user fees than allowed under a continuing resolution likely to be passed by the Senate this week, with possible legislative vehicles being the farm bill or legislation to avert a Medicare physician payment cut, sources said. The House on Wednesday passed a bill allowing for the collection of the newly authorized generic drug user fees, but the measure did not include medical devices (see related story).608 words

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars. Energy and Commerce Committee chair Fred Upton (R-MI) and ranking Democrat Henry Waxman (CA) quickly crafted the generic drug user fee fix bill after the House passed a continuing resolution last week without a provision sought by the Obama administration that would have allowed for collection of the new and increased fees under FDASIA.806 words

Rib-X Pharmaceuticals this week said it was one of the first companies to receive a qualified infectious disease designation under the recently enacted Generating Antibiotic Incentives Now Act, with company officials saying the designation occurred within the mandated 60-day time frame and the statute provided a "roadmap" for the process despite the fact that FDA has not yet issued policy. Another industry source said the agency's quick action "bodes well for the program" as it demonstrates that last-minute tweaks to the legislation enable FDA to act on designations before issuing regulations.623 words

The high-pitched debate over whether biosimilars should be named differently than the products they copy continues among biologics stakeholders as FDA remains mum on the issue, with an official from a company developing a biosimilar arguing that innovator biologics companies' stance that biosimilars should be given unique names for drug safety purposes creates a "slippery slope" which could draw small molecule drugs into the arena.1054 words

The lead House sponsor of the Pandemic and All-Hazards Preparedness Act urged stakeholders on Friday (Sept. 14) to exert pressure on Senate lawmakers to finish negotiations and pass a final bill, saying lawmakers are "90 percent there" on a compromise measure, which one stakeholder said may include an administration-backed strategic investor program. The comments came only days before Congress adjourns ahead of the elections, with the likelihood of finalizing the bill before November waning, and sponsors also said it will be difficult to get the measure passed during the lame duck.919 words

As lawmakers and food and consumer safety advocates continue to push FDA to ban bisphenol-A from infant formula packaging based on evidence suggesting manufacturers have abandoned use of the additive, industry stakeholders contend the action would be premature as some manufacturers are still interested in using BPA, which FDA has recognized as safe for use in infant formula packaging. A ban would create a burden on industry if the chemical had to go through the approval process again, the stakeholders say.962 words

Christopher Austin, a National Institutes of Health official and former Merck employee with a wide background in translational science, has been named director of the National Center for Advancing Translational Science, NIH Director Francis Collins announced Friday (Sept. 14). Austin, who has been serving as director of NCATS' Division of Pre-Clinical Innovations since the center launched in December, will succeed NCATS Acting Director Thomas Insel on Sept. 23.431 words

Groups of farmers and scientists, including a former FDA commissioner, Wednesday (Sept. 19) called on FDA and Congress to adopt a stronger stance against antibiotic uses in agriculture, a move a key lawmaker said could bolster growing public awareness of the issue of antibiotic resistance and support for congressional action next year. Donald Kennedy, who was FDA's top official in the late 1970s when the agency tried to restrict the use of penicillins and tetracyclines, said without regulations, FDA's new policies will not be taken seriously by industry.713 words

Lawmakers and consumer safety advocates are pressing FDA to establish standards for arsenic levels in food that include rice and rice products, following the release of a study which found varying levels of inorganic arsenic in rice product samples. FDA is also analyzing samples and cautioned against "getting ahead of the science," saying further analysis is needed.516 words

The Medical Imaging & Technology Alliance and the Advanced Medical Technology Association recently met with industry and regulatory representatives in China to discuss international harmonization, specifically mentioning challenges surrounding combination products and in vitro diagnostics. AdvaMed emphasized the need for a joint review mechanism for combination products and to move certain in-vitro diagnostics into lower risk regulatory categories, according to a press release outlining the meetings.175 words

House lawmakers are looking to limit HHS' use of its special hiring and pay authority following a recent Government Accountability Office report that found the agency's use of its authority to hire and pay specialists above the typical pay limit for federal employees increased 25 percent in five years, and the agency does not have reliable data to manage and provide oversight of the program. HHS told GAO it is taking steps to better oversee and manage its authority.637 words

The House approved by voice vote this week four health-related bills -- including a measure creating a pediatric research network at the National Institutes of Health -- while the Senate health committee favorably reported two companion bills this week along with a measure expanding research into preterm labor.280 words

Public Citizen has petitioned FDA to stop its longstanding practice of redacting portions of documents released to Freedom of Information Act requesters without giving requesters an immediate right to appeal within the agency. FDA should revise or revoke portions of the agency staff manual that implement the policy, according to the petition, sent to FDA Wednesday (Sept. 19).480 words

Michael Gruber, senior policy advisor for the House Energy and Commerce Committee, has been tapped as the Grocery Manufacturers Association's vice president of federal affairs starting Oct. 1, the trade group announced Monday (Sept. 17).180 words

The Pharmaceutical Research and Manufacturers of America announced Friday (Sept.14) that Ipsen Biopharmaceuticals and Onyx Pharmaceuticals would join the group as research associate members. The two companies join the association following a recent decision from PhRMA's board of directors to expand its membership.176 words

Democratic Sen. Dick Durbin (IL) told Inside Health Policy on Thursday (Sept. 20) that "any honest plan for deficit reduction puts everything on the table," comments that come as he and seven other senators from both parties continue to discuss a grand bargain on deficit reduction and as stakeholders are gearing up for a battle to avert the automatic payment cuts required under budget sequestration. Durbin would not provide any specifics on health sector cuts, but the framework unveiled last year by the "Gang of Six" had asked the Senate Finance Committee to find more than $200 billion in savings in addition to fixing and fully off-setting the Medicare physician pay formula.495 words

The Patient-Centered Outcomes Research Institute on Monday (Sept. 17) requested applications for $96 million in comparative effectiveness research. As with the first funding cycle, the projects correspond to four of the five areas in PCORI's research agenda:128 words

FDA will take a $319 million hit if mandatory across-the-board cuts take effect in January, according to an administration report released Friday (Sept. 14) outlining the impact of sequestration, which includes user fees. FDA funding advocates recently said sequestration would likely affect the fees, contrary to what was previously thought, leading to a bigger agency impact. The report also confirmed a bigger-than-expected hit to NIH, research advocates said.873 words