FDA is protected from more than $300 million in cuts until March as a result of the just-signed fiscal cliff package, but the agency could face additional cuts in the coming months as Congress looks to address the debt limit, pass a fiscal 2013 spending bill and address the delayed sequestration. Health funding advocates are gearing up to protect non-defense discretionary programs, including FDA, that could be cut in lieu of entitlement and tax reform, with the fiscal cliff package continuing the precedent of using discretionary funding as a deficit reduction tool.1111 words

A group of drug companies that manufacture orphan drugs were urging Senate Finance Committee leaders to include in any legislative package addressing the fiscal cliff a measure exempting drugs used solely to treat rare diseases from the health reform law's annual pharmaceutical fee, but the measure was not included in the final fiscal cliff deal signed into law this week.340 words

Hot-button drug issues that closed out 2012 are expected to re-emerge this year, although it is still unclear how lawmakers will tackle problems associated with developing a drug track and trace system and new drug compounding standards, according to sources monitoring these policies. Debate around these topics comes as lawmakers are set to debate two key pieces of legislation -- reauthorization of the Animal Drug User Fee Act and the stalled Pandemic and All-Hazards Preparedness Reauthorization Act -- that could guide or become bogged down by these outstanding drug issues.919 words

FDA's first biosimilar approval is not expected this year, but debate is anticipated at the federal and state level over substitution policies, including naming, interchangeability and automatic substitution standards, according to industry sources following the new pathway. Sources also said 2013 will be a critical year for smoothing out kinks in the biosimilar review process to determine whether the health reform-created pathway will prove lucrative to drug makers and provide health care savings.1065 words

Courts are set to weigh critical questions in 2013 regarding the extent of patent infringement safe harbors and whether several companies could be held liable for shared patent infringement, but the biggest case of the year will be the Supreme Court's review of a highly watched case discussing whether genes are patentable, Association for Molecular Pathology v. Myriad Genetics, an attorney for the Biotechnology Industry Organization said.1266 words

The U.S. District Court for the District of Columbia dismissed Endo Pharmaceuticals' lawsuit against FDA on Dec. 19, declining the company's efforts to pressure FDA to make a safety determination about a non-abuse deterrent formulation of the painkiller Opana before generic versions hit the market this year. FDA has said it will make a safety decision by May, but Endo and key lawmakers wanted the agency to act sooner before generics based on old painkiller formulas hit the market.551 words

The new chairman of the House FDA funding panel has a reputation as a cost cutter and has identified FDA oversight as one challenge he hopes to tackle in his new role, but sources said Rep. Robert Aderholt (R-AL) has not been involved closely with agency-related issues and noted that appropriators have less power in the current budget environment.603 words

Maryland Sen. Barbara Mikulski (D) will take the helm of the Senate Appropriations Committee in a move that could be beneficial to FDA, and potentially could bolster stakeholders' efforts to protect funding for health reform prevention and NIH research. Mikulski has strongly advocated on behalf on FDA in the past, and on the health reform front she played a key role in securing preventive care coverage for women. Mikulski also has actively advocated for NIH funding.788 words

The medical device industry is resuming its lobby for Congress to scrap the health reform-created medical device tax, now hoping that a repeal of the law's $30 billion excise tax will be taken up as lawmakers deal with broader tax and budget issues in the coming months. The device industry, having failed to get Congress to address the issue as part of its New Year's fiscal cliff deal, continues to play up the impact of the 2.3 percent device tax on jobs and patient care and touts bipartisan support in both chambers to repeal the fee, which went into effect Jan. 1.501 words

Food Safety groups said they will push for legislation to ban the sale of genetically engineered salmon and are considering legal action following FDA's release Dec. 21 of a draft environmental assessment of the AquAdvantage salmon and a preliminary finding that the fish would not have a significant impact on the environment. The FDA action is viewed by stakeholders on both sides of the issue as confirmation that the Obama administration plans to approve the salmon, paving the way for commercialization of the first genetically engineered animal intended for human consumption.1143 words

Invacare Corp, a medical device maker and distributor, signed a consent decree of permanent injunction with FDA that will require the company to stop manufacturing, designing and distributing manual and powered wheelchairs and wheelchair components, the agency announced Dec. 20. The consent decree, filed at the United States District Court for the Northern District of Ohio, compels Invacare to suspend business operations for two of its Ohio plants until it corrects all violations listed in the decree and has been notified by FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act.234 words

Helen Winkle, director of the Office of Pharmaceutical Science in FDA's drug center, retires Thursday (Jan. 3), center director Janet Woodcock announced in an internal email sent Dec. 20. Keith Webber, former acting director of the Office of Generic Drugs, will step in as acting director, according to the memo. Winkle played a key role in scientific issues surrounding biologics, among other issues.206 words

Last month, Rep. Fred Upton (R-MI) and Sen. Tom Coburn (R-OK) sent a letter to HHS requesting more information about how it planned to address the release of non-abuse deterrent versions of extended-release opioids. Impax Laboratories was granted a license from Endo Pharmaceuticals, the maker of the painkiller Opana, to market a generic version of the drug on Jan. 1, although a spokesman for the company said the product has not been launched yet.455 words

Rep. James Lankford (R-OK) will chair a reconfigured energy, health care and entitlements subcommittee within the House Oversight Committee, the committee announced Wednesday (Jan. 2). Previously, the Oversight health subcommittee did not have "entitlements" in its title, and the change could suggest that the issue will be a high-profile subject in 2013.215 words

HHS is facing pressure from 151 patient advocacy groups to further broaden the number of drugs that plans with essential health benefits must cover, with the groups saying in a recent letter that the administration's recent proposal doesn't go far enough for patients with complex medical needs. Instead of allowing drug formularies to vary highly by state due to HHS' essential benefits benchmark plan approach, the groups argue that plans should be required to cover all or close to all drugs in each class.726 words

FDA will likely move beyond supplement companies with glaring violations and also target smaller infractions as the agency continues to ramp up enforcement of dietary supplement current Good Manufacturing Practices, industry sources said. The trend began last year, with a high number of warning letters and lawsuits, according to one industry attorney, who said the trend would likely continue in 2013. FDA will also pay greater attention to adulterated dietary supplements and caffeinated energy drinks, agency officials said.972 words

It could take several years to fully address the drug shortage problem, despite a drop in shortages as a result of mitigation measures initiated last year, as the problem will likely continue until generic manufacturing facilities upgrades are complete, stakeholders monitoring the issue said. Further, researchers last month for the first time linked a drug shortage to an adverse impact on patients.1506 words

FDA hit a fresh set of deadlines for the Food Safety Modernization Act this week and a food safety advocate targeted the delayed implementation of food import provisions as a sore spot because those components of the law could be especially crippled by the still-looming sequestration. Meanwhile, the agency will focus on using the authorities already granted under the law and is gearing up for the release of delayed proposed rules early this year, an agency official recently said.

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The Supreme Court will weigh in this year on two issues that could have a major impact on how the generic drug industry does business, with the high court agreeing to hear a case on the legality of drug patent settlements between generic and brand-name drug companies and another examining whether generic drug manufacturers can be held liable for design defects. 1056 words

An array of stakeholders said they will be watching FDA's implementation of the FDA Safety and Innovation Act this year, particularly provisions related to medical devices, rare diseases and Risk Evaluation and Mitigation Strategies, although concerns persist about the resources available to fulfill the new mandates as there is still the looming threat of sequestration.1172 words

Groups pressing for animal antibiotic restrictions are turning their attention in 2013 toward the legislative front as Congress prepares to reauthorize animal drug user fees, while others continue challenging FDA's regulatory actions on antibiotics in court -- a move that has drawn more attention to the issue, one attorney said. Meanwhile, a heavily watched voluntary process to remove growth claims from animal antibiotic labels -- a process initiated nearly a year ago -- is not expected to progress much this year without FDA's finalization of critical documents directing the process, said industry and public health advocate sources monitoring the process.869 words