The full House Appropriations Committee's approval of an amendment to the FDA spending bill Tuesday (May 31) that would mandate the agency base its guidance or regulations purely on "hard science" stems from a lawmaker's concerns that FDA might limit antibiotic use in animals based on contentions that utilization of these drugs on the farm promotes antimicrobial resistance of bugs in humans. The measure garnered substantial opposition from key Democrats, FDA and many other stakeholders, with the amendment possibly set to be stripped from the bill before it hits the floor because it is not germane to appropriations and would better suit consideration by an authorizing committee.1224 words

FDA recently launched a new program to utilize patient, prescriber and other caregivers' smartphones to transmit adverse event reports to the agency, with the effort set for a pilot with medical countermeasures and possible deployment for other products regulated by the agency's drug center, an FDA official told FDA Week. The program reflects pressures on the agency to track products, particularly less-proven medicines, in real time and could reduce some FDA reticence to allow utilization of some drugs, sources said.1022 words

Stakeholders are pushing for more integration of Risk Evaluation and Mitigation Strategies into the existing health care technological infrastructure as FDA and industry recently agreed on ways to standardize the program, a topic that is being addressed through user fee negotiations and other agency efforts. Pharmacy stakeholders said verifying REMS under current technology involves switching modems or computers, which disrupts the workflow, an issue that has grown excessively burdensome with the increased number of REMS programs.581 words

Sen. Bernie Sanders (I-VT) is proposing establishing prize funds to pay innovators for developing new products but, in exchange, brand-name drug companies would lose all exclusivity rights -- including those provided by the Hatch-Waxman Amendments and the Orphan Drug Act. The plan could garner support from comparative effectiveness research advocates because it would incentivize the development of superior treatments, while also possibly gaining some traction with certain generic drug companies, although the bulk of the pharmaceutical industry would likely heavily oppose the measures, sources said.1179 words

ReGen Biologics is suing FDA over the agency's decision to rescind 510(k) clearance for the firm's knee implant, with the company contending that pulling clearance for the product exceeded the agency's statutory and regulatory authorities. FDA has said that it possesses the authority to take such action and is looking to clarify its ability to rescind 510(k) device clearances as part of its proposed reforms to the overall product review process, with safety advocates backing the move.845 words

Negotiations between FDA and industry over the fifth iteration of the Prescription Drug User Act have concluded, with the package now set for review by HHS and the White House's Office of Management and Budget, according to key industry officials.411 words

House appropriators are calling on FDA to examine ways to create an independent drug safety office, with the request following past attempts by lawmakers to mandate the establishment of a separate FDA division for postmarket surveillance. The House Appropriations Committee, which cleared the request Tuesday (May 31) as part of the FDA fiscal 2012 spending report, wants the agency to issue a plan by March 2012 outlining a process to create an independent FDA office that conducts postmarket drug assessments.542 words

A recent circuit court decision on diabetic test strips raised the bar for invalidating patents based on allegations of misleading the Patent and Trademark Office, establishing that in order to expunge a patent, any withheld information must affect whether the patent would have been granted. Known as the doctrine of inequitable conduct, the issue has been part of the debate surrounding patent reform on Capitol Hill, especially for generic manufacturers who utilize the argument that others misled PTO to help get their more affordable medications on the market.832 words

Republicans on the House Energy and Commerce Committee have expanded their inquiry into the contamination of China-sourced heparin beyond FDA and are now asking the Department of Homeland Security to hand over a trove of documents on the adulteration, which allegedly killed dozens of Americans in 2008. The interest in DHS' role via its U.S. Immigration and Customs Enforcement subcomponent stems from the customs investigation agency's involvement in the probe early-on and because it might have documents or information not provided by FDA, sources said.719 words

House appropriators are supporting an alternative version of an FDA menu labeling proposed rule, saying the health-reform mandated nutrition listing requirements should not be imposed on grocery and convenience stores, a move that a key stakeholder views as a clarification of congressional intent.420 words

House appropriators are seeking to mandate FDA release long-awaited sunscreen regulations by the end of the year, passing report language late Tuesday (May 31) out of committee that could finally spur agency action if the language is included with Congress' final funding measure, an advocacy organization said. The finalization of the sunscreen regulation has garnered Capitol Hill attention recently, with a Senate bill introduced last week mandating a final rule within 180 days of enactment, but past legislation pressuring the agency was unsuccessful.440 words

The Generic Pharmaceutical Association selected Jim Fenton, a long-time aide to former Sen. Chris Dodd (D-CT), as the group's senior vice president for government affairs, filling a top slot at the organization that has undergone major personnel shifts during the last year.374 words

House appropriators are arguing that FDA has the authority to approve adjuvants for seasonal influenza and are pressing the agency to begin using that power, although the agency has been reluctant to approve these products that extend the vaccine supply primarily due to safety concerns, sources said.752 words

A Government Accountability Office report released Tuesday (May 31) exemplifies how recently reauthorized legislative changes to spur pediatric research have been successful, American Academy of Pediatrics sources said, while other drug development incentive programs -- such as one to spur development of tropical disease products -- have not been nearly as effective.597 words

House Republicans proposed fixing delays and inconsistencies in FDA's medical product approval process as one of eight pillars in their economic growth and job creation plan unveiled last Thursday (May 26), with the GOP intending to address lags in drug and device review during upcoming user fee reauthorizations.143 words

FDA plans to increase its use of technology -- including piloting hand-held devices -- as part of its food safety enforcement and compliance program, especially as lawmakers threaten deep cuts to the agency budget, forcing the regulator to attain the same auditing standards with strained resources, the agency's top enforcement official told FDA Week.588 words

A consumer group is urging FDA to incorporate import certifications required under the new food safety law with existing mandated prior notifications of arrival at U.S. ports of entry, saying FDA could use existing technological infrastructure to integrate the two requirements and contending that the coordination would give government officials more information on products before they arrive. Consumers are also pushing for a definition of risk overall because it will determine how components, like import certifications, are applied, potentially using recalls and enforcement actions as a metric.643 words