The Federal Trade Commission is considering asking the Supreme Court to decide if drug patent settlements between brand and generic manufacturers violate antitrust law in the wake of two lower court rulings this week that lawyers say accentuate a growing split on the issue and increase the likelihood the high court will weigh in after having punted last year. The U.S. Court of Appeals for the 11th Circuit denied on Wednesday (July 18) the FTC's request for rehearing en banc of a ruling that such pacts are legal, with the decision coming only days after the U.S. Court of Appeals for the 3rd Circuit ruled that so-called pay-for-delay patent settlements between brand and generic drug manufacturers violate antitrust law.1813 words

HHS last month asked its Office of Inspector General to investigate the premarket review process for some medical device applications that have been caught up in FDA's controverisal employee monitoring activities, FDA said in a recent letter to Sen. Chuck Grassley (R-IA), responding to the senator's months-long probe into the employee surveillance policies. The OIG's involvement comes as FDA prepares to implement expanded whistleblower protections in the new FDA Safety and Innovation Act and as the agency asserts that its surveillance activities were linked to confidential information leaks. Still, questions from lawmakers persist as recent documents and news reports indicate FDA monitoring of agency staff interactions with journalists, outside groups and congressional offices was more widespread than initially thought.870 words

A group of health care journalists has asked HHS to contact reporters that were caught up in FDA's controversial effort to track agency employees' communications with outside parties, adding to the growing outcry over reports that FDA monitored emails of agency employees suspected of leaking confidential information. The Association of Health Care Journalists said the incident builds on the fact that journalists have "long chafed" under restrictions from government press offices.529 words

FDA Friday (July 13) named Gregory Geba director of the agency's Office of Generic Drugs, with the former deputy chief medical officer of Sanofi US arriving as FDA prepares to implement a significant new generic drug user fee program. Having a permanent director -- after two years of waiting for the appointment -- will bring regulatory stability to companies as they head into user fee implementation and industry growth, an industry source said. A director with company experience may also benefit generic drug firms by bringing to the job a perspective on timeliness and approvals, regardless of whether the experience is with brand or generic companies, the source noted.672 words

A bipartisan duo of lawmakers has introduced new legislation that would require tamper-resistant formulations of all brand and generic painkillers, with the legislation directing FDA to establish a timeframe for manufacturers to change already approved drugs and make tamper-resistance a condition of future approvals. The new bill comes on the heels of the recently signed FDA Safety and Innovation Act that includes provisions addressing drug abuse-deterrent products and hydrocodone scheduling.421 words

A Senate advocate of bolstering FDA's nanotechnology research will pursue funding for activities outlined in the recently signed FDA Safety and Innovation Act, even though lawmakers dropped language explicitly establishing a new regulatory science program, a congressional aide said, noting that the provision's core functions remain. One nanotechnology researcher said the law's language will not add to FDA's current work on nanotechnology, but a consumer safety advocate said the measure could bolster agency requests for additional nanotechnology funding.734 words

House lawmakers are refocusing efforts to remove catfish inspection authority from the Department of Agriculture and return it to FDA, with lawmakers looking to de-fund the USDA program in the appropriations bill after a measure to axe the program failed to make it into the lower chamber's committee-passed farm bill. While appropriation solutions would be temporary, the prospect of including a permanent provision in the farm bill is unclear as the House legislation is on hold, although the catfish measure was included in the Senate-passed version.637 words

The top innovator drug industry groups are telling FDA that pharmacy concerns about information technology systems' ability to process unique naming schemes for biosimilars are "misplaced." Pharmacy groups have said there could be safety issues associated with having separate names for a biosimilar and its reference product, and support tracking biosimilars by their National Drug Code as opposed to a unique name. The innovator drug industry has lobbied FDA to require separate names as it implements the health reform law's biosimilars approval pathway, but generic drug makers say such a policy would stifle interchangeability of products and have pushed for biosimilars and their reference product to have the same name.413 words

FDA's decision this week to ban the use of bisphenol-A in baby bottles and sippy cups gained lukewarm praise from food safety advocates and a Democratic lawmaker who questioned the agency's ability to enforce its ban and called for more aggressive action to also block use of BPA in other food contact substances.1285 words

A coalition of food safety and consumer advocates took the Obama administration to task in a full-page New York Times ad that criticized the president for not releasing four proposed food safety rules that have been held up at the White House Office of Management and Budget and that they said were the muscle behind the Food Safety Modernization Act.384 words

The Produce Marketing Association and United Fresh Produce Association said Tuesday (July 17) they abandoned efforts to combine the two associations after failing to reach an agreement on how to merge the goals and priorities of both. PMA said that it ended the talks after the two associations were unable to agree on an acceptable joint model that would meet its members and industry's needs.352 words

FDA's decision late Tuesday (July 17) to approve the second weight-loss drug in less than a month could help establish efficacy standards for obesity control drugs coming through the pipeline, stakeholders said in anticipation of the subsequent second clearance. FDA's approval of Qsymia, a combination of two FDA-approved drugs that the agency's top drug official said could be used in addition to diet and exercise for chronic weight management, comes with a Risk Evaluation and Mitigation Strategy that includes prescriber and pharmacy certification requirements. 459 words

Stakeholders said proposed FDA x-ray labeling, which cautions against the device's use in children if there is not data to back up the pediatric use, could force hospitals to use the devices off-label and proposed alternatives, including labeling with the intended use of the device. Stakeholders said x-ray devices already make accommodations for children and worried the FDA-proposed labeling would limit the number of devices available for pediatric uses as companies might not seek the data to make pediatric claims.1009 words

House appropriators on Wednesday (July 18) cleared a bill that would cut more than $1 billion from HHS in fiscal 2013, defund the healthcare law and put a prohibition on providing any new discretionary funding for the law's implementation. The bill also proposes cutting all funding for the Agency for Healthcare Research and Quality and patient-centered outcomes research, flat funding for the National Institutes of Heatlth and would require the agency to issue a rule ensuring activities of the National Center for Advancing Translational Sciences do not create duplication, redundancy or competition with industry. The proposal puts the lower chamber on a collision course with the Senate, where appropriators are pushing to boost CMS funding to implement the health law and slightly increase NIH funding.745 words

FDA Monday (July 16) approved Gilead Sciences' Truvada, the first drug cleared to reduce the risk of HIV infections in high risk individuals, with the agency hoping that training and education required through a Risk Evaluation and Mitigation Strategy will help minimize the risk of uninfected individuals acquiring the infection. The prevention indication has stirred controversy in the AIDS treatment community, where groups' support varies, including one that filed citizen petitions encouraging FDA to reject the drug and questioning potential conflicts of interest on the advisory committee considering it.438 words

The creation of a public database of 100,000 foodborne pathogen genomes could lead to the creation of new tests for detecting foodborne illness and biologic threats, aid the regulated food industry in tracking the source of ingredients and disease prevention, strengthen efforts to address antibiotic resistance, lead to development of new genetic analysis software and help combat multi-drug resistant bacteria, officials with the new 100K Genome Project said.628 words

CMS may scrap the one drug per class essential benefits coverage standard included in its December bulletin that was roundly criticized by stakeholders representing patients and those with chronic disease, and is considering two other policies that would provide a more robust formulary, sources tell Inside Health Policy. The agency also faces new pressure from Congress to change course, with 28 House Democrats sending a letter Thursday (July 12) that calls for CMS to adopt an EHB approach that mirrors Part D's six protected drug class policy.984 words

A consumer safety advocate said she was concerned about FDA allowing manufacturers and healthcare providers to use existing device identification schemes to comply with the proposed Unique Device Identifier rule, which does not pinpoint specific technologies, but sets forth requirements, because the multiple identifier systems could make it more difficult to track device information. But a Premier healthcare alliance source said there are two systems that would meet FDA's UDI requirements and having those two would narrow down the slew of systems currently used, although it would be useful for industry to eventually adopt just one set of standards.824 words