FDA's 2005 decision to allow a compounding pharmacy to link patients with prescriptions retroactively through a barcode program possibly conflicted with state laws and encroached on states' authority to determine valid prescriptions, said the International Academy of Compounding Pharmacists, reacting to FDA's recent move to backtrack on the barcode pilot study. FDA tells FDA Week the program was limited to the one compounding firm, PharMEDium Services.799 words

The National Association of Boards of Pharmacy, in conjunction with the Iowa Board of Pharmacy, has been targeting out-of-state pharmacies that ship products to Iowa, inspecting and obtaining information about the non-resident firms for broader use by other state regulators, an Iowa pharmacy official said this week. The action at the state level coincides with efforts by federal lawmakers to beef up FDA oversight, including another bipartisan effort in the House, with a compounding executive calling for federal action to prevent continued uneven enforcement at the state level.919 words

FDA told an Illinois-based compounding pharmacy earlier this week that it no longer stands by an enforcement discretion policy laid out in 2005 that allowed the company to link patients to prescriptions after the compounded product was shipped to hospitals, rather than requiring an individual prescription in advance. The letter -- sent Feb. 5 -- signals that the agency is reexamining past flexibility on patient-specific prescriptions -- one of the key factors used to identify whether firms are compounding facilities or drug manufacturers.838 words

An Institute of Medicine report recommending creation of a federal drug track and trace system fueled calls by lawmakers and stakeholders this week for creation of such a system this year. The move comes as the Senate advanced pandemic preparedness legislation this week that did not include a federal track and trace measure, although sources said talks on the issue continue, with draft legislation expected soon.1236 words

Mississippi state legislators recently balked at proposals requiring patient consent before and physician notification after a biosimilar substitution takes place, making Mississippi the first state among many floating biosimilar bills to pass on legislation. State lawmakers, backed by some innovator biologic companies and industry organizations, have introduced a slew of proposals to limit substitution in the opening months of 2013, but one source pointed out the move could increase originator biologic competition by making biosimilar development less lucrative and adding to the hurdle of achieving interchangeability and substitution.814 words

A Democratic lawmaker said he is eying a bill reauthorizing animal drug user fees as a vehicle for legislation banning genetically engineered salmon, a topic that has heated up with FDA's recent assessment in favor of allowing the product on the market. The action comes as an industry attorney said food issues, including the delayed implementation of the Food Safety Modernization Act, are ripe for congressional consideration alongside the reauthorization process set for this year.1066 words

FDA stopped short of agreeing with the HHS Office of Inspector General's call that the agency seek new legislative authority to enforce Risk Evaluation and Mitigation Strategies developed for higher risk drugs, saying it would pursue such changes if the opportunity arose. A newly released OIG report notes FDA lacks legal authority to require pharmaceutical companies to submit REMS information and recommends the agency seek authority to take enforcement actions when sponsors do not submit data needed to determine if REMS effectively mitigate risks.774 words

Two companies jointly developing a cancer drug that recently received FDA's new breakthrough status said the implications of the designation are unclear and they are working with FDA to identify the pathway's impact on development activities. The cancer therapy ibrutinib received two breakthrough designations to treat two types of lymphoma, representing the first oncology designations since the accelerated development pathway was created with enactment of the FDA Safety and Innovation Act in July.683 words

Sources expect a bill reauthorizing HHS medical countermeasure programs to easily move through both chambers of Congress now that a consensus has been reached between the House and Senate. The Pandemic and All-Hazards Preparedness Act does not include an administration and Senate-backed strategic investor program, but sources say discussions on how to move forward with the program could continue although the program will likely face legislative and fiscal challenges.1068 words

FDA is looking at collecting more information about manufacturing quality, setting up a public-private development program and offering market incentives as new ways to encourage drug manufacturers to produce high-quality products and expand their manufacturing capacity to avert medication shortages, proposals that one source said could spark controversy among stakeholders. The ideas floated by FDA come after agency officials recently cited the failure of the market to reward quality as a fundamental driver of manufacturing problems causing drug shortages and advocated giving purchasers and providers information on quality differences to help reverse the trend.1084 words

Arkansas Sen. Mark Pryor (D), as expected, will chair the panel with jurisdiction over FDA's funding, while Sen. Roy Blunt (R-MO) will remain in the ranking spot, the Senate Appropriations Committee said Tuesday (Feb. 12). As expected, Sen. Tom Harkin (D-IA) will remain at the helm of the labor-HHS appropriations subcommittee, but Sen. Jerry Moran (R-KS) will take over as ranking.177 words

The looming budget sequester, if allowed to kick in, could hinder FDA's ability to participate in an interactive review process that fosters the approval of novel vaccines, FDA's chief scientist told lawmakers at a House Energy and Commerce oversight hearing. Flu vaccine manufacturers gained approval using two novel production techniques in recent months and increased production capacity in recent years, but more effective treatments would improve preparation for seasonal outbreaks and pandemics, the FDA official told lawmakers.586 words

The staggered release of FDA's food law rules is raising concerns about how companies, especially those importing from foreign countries, will apply new produce standards and preventive controls to forthcoming foreign supplier verification requirements, a former Senate staffer said. However, a consumer safety advocate urged FDA not to delay implementation of the two rules that have been released, saying the later rules will provide "checkpoints," but produce and preventive control standards should already be in place.626 words

The hiring of a biotechnology industry executive to oversee science operations in FDA's drug center gives the agency "substantial, practical experience at the top" that could help inform regulatory decisions, a former FDA official said. The agency announced this week that Richard Moscicki, senior vice president and head of clinical development at Genzyme Corporation, will take on the new role of deputy center director for science operations, with FDA's top drug official also highlighting Moscicki's expertise in clinical research and development in an email to staff on Tuesday (Feb. 12).461 words

Sen. Jay Rockefeller (D-WV), who has floated legislation on opioids, sent a letter to FDA on Tuesday (Feb.12) asking that when it reviews its methadone dosage recommendations and amends current methadone labeling to include information about the risks to first-time users. The lawmaker also sent letters to CMS and the Government Accountability Office asking those agencies to also take steps to address prescription drug abuse.384 words

The Center for Science in the Public Interest and a coalition of scientists and physicians urge FDA to determine a safe level for added sugars in soft drinks in a petition sent to the agency Wednesday (Feb.13), citing evidence showing added sugars cause weight gain, obesity, as well as chronic diseases like diabetes. The move comes as some health care stakeholders are advocating a tax on sugary drinks as a way to help offset the deficit as well as reduce health care spending.392 words

President Obama's allusion during his State of the Union address to extend Medicaid drug rebates to Part D has pleased supporters of the controversial deficit-cutting policy and immediately sparked an angry reaction from the pharmaceutical lobby, who criticized the proposal as "radical" price controls that would destroy the program's success. In a move that would build on the president's call, sources tell Inside Health Policy that Sen. Jay Rockefeller (D-WV) plans to drop a Part D rebates bill after lawmakers return from Presidents Day recess.885 words

A group of key GOP lawmakers - including Senate Finance ranking member Orrin Hatch (UT) and Finance members Charles Grassley (IA) and Mike Enzi (WY) -- has asked the Health Resources and Services Administration to detail its audits of hospitals covered by the 340B drug discount program as well as the 2012 certification process, including a description of any entities decertified by the agency. The group representing 340B hospitals applauds the congressional interest in HRSA's work, but adds that several other program integrity provisions supported by Congress -- including price transparency, establishment of a meaningful dispute resolution process and drug manufacturer audits -- have never been implemented.860 words

Requirements for food companies to validate and verify preventive measures -- in addition to identifying hazards reasonably likely to occur in facilities -- extend beyond what companies currently use for hazard analysis and critical control points plans and could provide a disincentive for companies to fully identify hazards as required by Food Safety Modernization Act rules, an industry attorney said. However, a consumer safety advocate dismissed the idea as an attempt to avoid compliance.793 words