Lawmakers and congressional staff are regenerating efforts to establish a national drug track and trace system and started meeting to discuss the topic this week, including discussions with FDA, several sources said. Sen. Dianne Feinstein (D-CA) is also involved with the ongoing bipartisan talks, a move that could assuage concerns from California stakeholders implementing an upcoming state law that has served as a catalyst for developing a national standard, an industry source said. Lawmakers hope to reach agreement on the issue in time to attach the measure to the Pandemic and All-Hazards Preparedness Act, which is expected to move by the end of the month, ahead of August recess (see related story).474 words

Stakeholders watching the reauthorization of the Pandemic and All-Hazards Preparedness Act expressed concern this week that the bipartisan bill reauthorizing HHS medical countermeasure programs could become a Christmas tree for other provisions that failed to make it into the final FDA user fee bill, including a drug track and trace measure. But sources said they are optimistic that the bill will be completed soon, with staff working out minor differences between the Senate- and House-passed versions in hopes of passing a final bill before the August recess.1142 words

Mylan Pharmaceuticals is suing brand drug companies for making dosing and scoring changes to an antibiotic ahead of abbreviated new drug application approvals, alleging the product changes are aimed at blocking generic competitors from the market and citing several instances of such brand company moves. A former Federal Trade Commission official and antitrust attorney said a ruling in favor of generics could curb such practices by other brand drug companies.734 words

Dietary supplement trade associations said they are working with FDA officials to educate firms about current Good Manufacturing Practices in response to lawmaker inquiries that came in the wake of FDA assertions in a news article that the industry was failing to comply with manufacturing regulations. One trade association called the agency's comments "reckless" and another highlighted how industry is already staving off legislative efforts, saying the agency had adequate authority to deter violations.994 words

President Barack Obama's signing Monday (July 9) of the FDA Safety and Innovation Act officially sets in motion implementation of the law that reauthorizes and establishes product user fees, and mandates several key reforms. With the bill's enactment, reforms such as tools to prevent drug shortages and antibiotic exclusivity incentives are immediately available, but the agency must also develop several policies in the coming years, such as questions ranging from social media regulation to antibiotic development.960 words

Stakeholders are watching to see how FDA determines which drugs will be subject to early warning notification requirements included in drug shortage provisions of the FDA Safety and Innovation Act, how quickly it ramps up staffing in its generic drug office in light of new user fees and if there is additional funding for the agency's drug shortage program as it works to implement the new measures.1563 words

The Obama administration rebuffed physicians' concerns by reasserting its call this week for Congress to mandate prescriber training as part of Drug Enforcement Administration registration. The move came as FDA on Monday (July 9) approved a Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids that for now includes voluntary educational components. Physician groups have argued that mandatory training would be burdensome, but FDA Commissioner Margaret Hamburg expressed hope that the voluntary program could lead to "greater receptivity" of a mandatory approach.757 words

KV Pharmaceutical's decision late Thursday (July 5) to sue FDA for allowing compounded versions of the company's pre-term labor drug to remain on the market may force the agency to firm up long-standing ambiguity regarding its compounding enforcement stance as well as where it stands on orphan drug exclusivity and importation of active pharmaceutical ingredients. The policy stakes are high not just for FDA, but also for CMS and state Medicaid agencies which have allowed continued coverage of the vastly less expensive compounded versions of KV Pharmaceutical's FDA-approved drug Makena. KV Pharmaceutical says failure to resolve the issues in its favor could drive the company to bankruptcy.839 words

House appropriators' report language directing HHS and the Department of Agriculture to seek public comment on changes to sales and distribution data for antibiotics used in animals represents a toned-down approach from language pushed by a group of Democratic lawmakers, including Rep. Louise Slaughter (NY). It may be difficult for antibiotic control advocates to get more stringent animal antibiotic reporting requirements in the upcoming animal drug user fee bill, a congressional source said, who also viewed the appropriations language favorably.604 words

The generic drug industry is focusing on implementing its Accelerated Recovery Initiative to address the drug shortage crisis following passage of the FDA Safety and Innovation Act, with the major generic pharmaceutical trade association meeting with FDA and the Federal Trade Commission to implement ARI. The move comes as stakeholders continue to advocate for additional legislation to combat the drug dearths, although sources said congressional action in this area is unlikely in the coming months but outcomes of the ARI and drug shortage provisions included in FDASIA could help spur further action.1335 words

A House FDA Appropriations bill that leaves no money to outfit the agency's new lifesciences-biodefense laboratory is likely a political move, but it could mean less money for staff and programs if enacted, one source said. The bill also appears to have stripped funding for building and facilities repairs to beef up money for the agency's centers, the source added.773 words

A new public database of 100,000 foodborne pathogen genomes being created by FDA, CDC, the University of California Davis and Agilent Technologies will help speed identification of bacteria responsible for foodborne outbreaks and could significantly reduce the time it takes public health officials to pinpoint the source of contamination and respond to these outbreaks, FDA announced on Thursday (July 12).316 words

A consumer safety advocate said she would like further clarity on which over-the-counter devices FDA plans to exempt from the Unique Device Identifier rule saying some OTC devices like inhalers should still be monitored. Other safety advocates floated ideas for expediting the implementation timeline for implantable devices in lower risk categories, such as requiring compliance within the first year of implementation alongside class III high-risk devices. FDA has yet to incorporate changes required by the FDA Safety and Innovation Act that will push implementation forward for some devices.666 words

House Appropriations Committee Chairman Hal Rogers (R-KY) on Wednesday (July 11) chided Senate Democrats' refusal to act on any fiscal 2013 spending bills before the November elections, with the lower chamber prepared to take up another set of appropriations bills next week, which could include the Agriculture-FDA funding bill that passed out of committee last month.428 words

A food safety advocate said a recent settlement between Pfizer and the Center for Science in the Public Interest to nullify the supplement maker's breast and colon health claims shows FDA is failing to take action against dietary supplement companies' deceptively labeling their products. But an industry attorney and free speech advocate said Pfizer's claims were within the boundaries of dietary supplement statutes and doubted whether other cases against companies focused solely on supplement manufacturing would be successful.795 words

State Medicaid directors have sent a barrage of questions to CMS in a quest for policy direction on key Medicaid expansion issues that have been left unclear by the Supreme Court's recent health reform ruling, including whether a state can do a limited expansion of Medicaid eligibility instead of completely expanding to 133 percent of the federal poverty level as called for by the law, if states can phase-in their expansion to low-income adults beyond 2014, and whether states that previously expanded Medicaid eligibility would be eligible for the law's higher matching rate even if they decide against proceeding with the full expansion.671 words

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.664 words