At the request of the Obama administration, Senate and House appropriators are negotiating the inclusion of a provision in a six-month continuing resolution allowing FDA to collect user fees for generic drugs and biosimilars, a source said. Meanwhile FDA appears to have a plan in place to move forward with the generic drug user fee program, laying out collection procedures in a recent guidance document if there is not a spending bill at the beginning of the fiscal year to appropriate some fees under the new program.878 words

The Federal Trade Commission and private plaintiff's attorneys could bring more challenges to drug patent settlements and fewer companies might enter into these agreements, sources said, citing possible ramifications as the Supreme Court decides if and how it will take up the issue following a brand company's petition asking the high court to allow the settlements. The company's filing also complicates FTC's next move because seeking Supreme Court review in a separate case that was not favorable to the commission could nullify the more favorable standing it has in the case drug companies are challenging, attorneys said.1118 words

Use of a Hatch-Waxman patent infringement exemption could be further defined by the Supreme Court in a set of cases that are ripe for high court review and could have ramifications for the burgeoning biosimilar industry, attorneys watching the issue say. A recent appeals court ruling saying Amphastar Pharmaceuticals did not infringe on patents for batch testing methods because the tests were necessary to maintain FDA approval, and thus available for exemption, raises questions about how the infringement safe harbor should be defined in light of the growing biosimilar market, the attorneys say.904 words

Stakeholders said if U.S. trade negotiators close a deal with several Asia-Pacific partners that includes less than 12 years of data exclusivity for biopharmaceuticals it could deter venture capital investment in the life sciences, with one venture capitalist saying reduced exclusivity could make the life sciences industry, which is already facing a funding crisis, even less attractive to investors. The U.S. health reform law includes 12 years of exclusivity for biologics as part of a carefully crafted compromise creating a new FDA approval pathway for biosimilars.930 words

Smaller producers' efforts to be exempted from requirements in FDA's final egg rule could provide clues as to how small farms and companies might seek exemptions to food safety law regulations, one food safety advocate said. But an industry stakeholder said it would be difficult to draw such conclusions before new food safety rules are released and FDA provides more insight into how it plans to interpret the law.876 words

Food & Water Watch, along with pet food safety advocates, sent a letter to FDA Thursday (Aug. 30) urging the agency to use new food safety law authorities to block imports from countries where FDA inspectors have been denied access, citing issues with the Chinese government when inspecting facilities producing chicken jerky treats believed to have caused a pet illness outbreak. The group also pushed for stronger consumer alerts about safety issues tied to those products. The organization also said it planned to send a citizen petition on the issue to FDA on Friday (Aug.31).527 words

KV Pharmaceutical last week brought the company's third case against a state agency for coverage practices surrounding the controversial preterm labor drug Makena, with the drugmaker reasserting in Illinois that because compounded drugs are not approved by FDA, copycat versions of the injection are not eligible for coverage. A compounding pharmacy source said while states could reimburse compounded drugs made from active pharmaceutical ingredients, they cannot use federal funds to do so, but states opting to fully foot the bill for compounded drugs could save more money in the long run. Still, state policies cannot favor the compounded version over the FDA-approved version, the source said, reflecting on the crux of pending lawsuits.936 words

The U.S. Court of Appeals for the District of Columbia Circuit on Friday (Aug. 24) blocked FDA's attempt to implement cigarette warning label requirements, teeing up a potential Supreme Court review as Friday's ruling conflicts with a different appeals court decision, according to several groups pressuring the government to continue defending the labels. Drug industry attorneys are monitoring the case because of its potential implications for broader commercial speech, like off-label drug promotion, but a Washington Legal Foundation source said there will be little spillover into other FDA-regulated areas under the high court's likely review.842 words

Dietary supplement groups said statutory language distinguishing a dietary supplement from a conventional food is analogous to the standard FDA uses for regulating medical products and does not warrant a change to the Dietary Supplement Health and Education Act. The comments follow FDA's assertion that the language put in place by the 1994 law is a more difficult standard for the agency to meet when assessing whether conventional foods are wrongfully marketed as dietary supplements.963 words

Rep. Ed Markey (D-MA) is prioritizing bills that would expand clinical trial reporting requirements to include early phase drug and device studies, and allow FDA to reject new devices based on flawed predicates, his office said, referencing the lawmaker's plans for next year. An industry attorney, meanwhile, expressed doubt that predicate nullification measures, which were hotly debated during the passage of user fees, would progress.612 words

Republicans are targeting reform of FDA to foster innovation in the drug and medical device sectors as part of the party's platform unveiled at the GOP convention this week, saying a lack of predictability, consistency, transparency and efficiency at the agency is driving companies overseas.322 words

FDA on Monday (Aug. 27) approved a new combination pill to treat HIV in adults that have never been treated for the infection, touting the decision as a move that would provide a complete regimen for HIV infection. Stribild contains two new drugs -- elvitegravir and cobicistat. It also contains emtricitabine and tenofovir distenofovir disoproxil fumarate, a combination that was approved in 2004 and marketed as Truvada. FDA also approved a prevention indication for Truvada, which blocks the actions of another enzyme that HIV uses to replicate in a person's body, in May (see FDA Week, May 11).154 words

Food and environmental safety advocates are seeking a court order to require FDA to release food safety law regulations by a court-imposed deadline and prevent the White House Office of Management and Budget from delaying FDA's compliance with that deadline, according to a lawsuit filed Wednesday (Aug. 29).279 words

The Department of Homeland Security plans to beef up its oversight of federal agencies' efforts to protect federal workers against an influenza pandemic, responding to pressure from Congress' investigative arm. The Government Accountability Office's call for greater oversight comes as part of a report finding uneven efforts by federal agencies to protect their workers against flu outbreaks. The GAO study coincides with HHS efforts to increase flu vaccination rates among health care workers, with an HHS advisory panel recently urging the department to endorse mandatory inoculation.681 words

CMS rolled out guidance and held a two-day summit with state Medicaid and federal leaders on psychotropic drug use in vulnerable populations, particularly foster children and dementia patients on Medicaid and CHIP, and as part of a coordinated multi-agency effort to strengthen oversight and monitoring of psychotropic drug prescribing practices. The summit came days after CMS issued guidance on Friday (Aug. 24) calling for states to use the Drug Utilization Review program to conduct oversight of psychotropic drug prescribing and urging development of state coalitions to strengthen outreach efforts to nursing homes.750 words

As retail pharmacists brace for significant Medicare pay cuts for diabetic testing supplies, some in industry are looking to getting reimbursed for counseling diabetics as a way to keep test strips and other diabetic supplies on their shelves. Retail pharmacists say they will stop selling the supplies if CMS cuts payment anywhere close to the competitive bid price for mail-order supplies, but if Medicare were to pay pharmacists for counseling diabetics, that would both save Medicare money and provide pharmacists a way to continue selling supplies, industry sources say.644 words

A drug company has asked the Supreme Court to reverse a lower court's ruling that settlements whereby brand drug makers pay generic drug companies not to market generics until a given date violate federal antitrust law, setting up the possibility the high court will rule on what petitioners called one of the most significant unresolved legal questions currently affecting the pharmaceutical industry. Court watchers are expecting the high court to agree to take up the issue after an appeals court -- in a clear split from other circuit courts -- ruled in July that these pacts were anticompetitive, with the Federal Trade Commission also weighing asking the Supreme Court to review a separate patent settlement decision.816 words

The Patient-Centered Outcomes Research Institute announced it will hold three workshops this year to engage patients in setting its research agenda and says it is still working on a process for selecting research topics.113 words

The U.S. pharmaceutical industry is not yet worried about Russia's delay in implementing a six-year data exclusivity period for pharmaceuticals, even though Russia was obligated to have this measure in place upon its accession to the World Trade Organization last week, industry sources said.515 words

A National Institutes of Health report analyzing an outbreak of antibiotic-resistant bacteria at the NIH Clinical Center in 2011 spurred calls from a lawmaker and public safety advocates for FDA to move forward with antibiotic policies intended to spur the development of new products and curb growing resistance to existing antimicrobials.607 words