The Agency for Healthcare Research and Quality is studying ways to get the public involved in deciding how comparative effectiveness research should be used in health care decisions, sparking mixed stakeholder response.

A new study suggests that the False Claims Act is not effectively stemming off-label marketing by drug manufacturers under investigation and that more enforcement is needed from FDA and the Department of Justice.

A recommendation by a White House-backed bioethics commission to create a government-wide template for informed consent would have little value for FDA, given the complexity of research that falls under the agency's purview and existing tools for monitoring clinical trials, according to a human research expert.

Recent guidance on a program that addresses repayment to Medicare for medical services that are subject to repayment due to a settlement will go a long way toward streamlining the process, trial lawyers and other stakeholders say.

The lead author of a recent provider-linked study on accountable care organizations said ACOs could ultimately help fill health system gaps in rural, under-served areas -- if they mature with the right economic incentives.

FDA's recent decision to relax the Risk Evaluation and Mitigation Strategies (REMS) for two drugs used to treat low blood platelet counts shows the agency's flexibility in reassessing REMS requirements after products are marketed for some time, a pharmacy source said.

The Biotechnology Industry Association and Pharmaceutical Research and Manufacturers of America are calling for the eventual elimination of a development fee aimed at funding FDA's initial biosimilar review activities while the biosimilars industry is still in its beginning stages, with the groups saying it is a "stop-gap" measure and should not set a precedent for a similar fee for drug development.

The moderate New Democrat Coalition will push for reforms to FDA's approval process, including providing more transparency to industry and developing new approval pathways, during reauthorization of user fee legislation next year, according to a white paper released by the 42-member House coalition, which also calls for changes to the CMS reimbursement process.

Women's health advocates are praising FDA for what they say is a long-overdue move to prod medical device makers to include more women in clinical trials, but say more needs to be done to ensure women are actually included.

State Medicaid officials are urging CMS to hold off on plans to revise Medicaid managed care regulations as part of an effort to align them with rules for qualified health plans that will be sold in exchanges, saying states need more time to understand potential inconsistencies between exchanges and rules for Medicaid health plans before a formal rulemaking is launched.

Congress has blocked a contentious plan by the Occupational Safety and Health Administration (OSHA) to add a category specifically for musculoskeletal disorders (MSD) to the injury recordkeeping logs kept by employers, a move that has implications for health care workers.

Groups are challenging FDA's method for determining allocation of fees under the food safety law even as the agency delays the policy and plans to release a temporary exception to alleviate potential economic hardship caused by the fees associated with facility and import reinspections as well as recalls.

The Institute of Medicine is recommending a drug-like structure for the approval and surveillance of modified risk tobacco products, with a study unveiled Dec. 14 saying randomized controlled trials should be used to determine exposure reduction, self-administration and effects of use on conventional tobacco products.

FDA's top biosimilar official clarified that there will be a clear separation between biosimilar and biologic submissions, easing concerns among some brand biologics makers that the agency could adopt an abbreviated biologics license application process alongside the biosimilar pathway.

Hospital advocates want CMS to clarify that its proposed Conditions of Participation (CoP) rule permits hospitals to consolidate staff post-mergers even if they have separate provider certification numbers.

Consumer advocates would like to see CMS take a step beyond its recent Medicare claims-data sharing measure and encourage nationwide use of the data collected under the health reform law provision, Consumers' Checkbook President Robert Krughoff tells Inside Health Policy.

Sens. Michael Bennet (D-CO) and Bob Casey (D-PA) spearheaded a letter sent Thursday (Dec. 22) asking the Treasury Department to include in its final regulations on premium subsidies an exception that would allow married victims of domestic abuse to file taxes separately, yet still receive the subsidies to purchase insurance through an exchange.

A dietary supplement company's push for a master file system that would allow new dietary ingredient submissions to reference safety data from other filings could gain traction as FDA's top dietary supplement official signaled consideration for the idea this week.

Ranbaxy Laboratories has committed to take certain actions to ensure data quality and integrity as the company and FDA settle high-profile compliance issues with a proposed consent decree that includes three top company officials, according to an industry attorney, who indicated that pressure on FDA to let the company market its generic version of Lipitor led to the drug's approval followed by the enforcement action.

Tucked into the now-stalled House “doc fix” bill is a measure that would establish a new process for allowing beneficiaries to receive therapy services above the capped amount and would lay out a path for reforming the payment system for such services.