The Generic Pharmaceutical Association membership approved changes late last week to the group's governance structure that will provide larger firms with more clout, a move that could entice drug industry giant Teva to return to the organization and help provide a more unified industry voice as FDA moves forward on establishing generic drug user fees, according to several informed sources.

Community and chain drug store pharmacists are praising CMS' recent proposal to withdrawal regulations affecting reimbursement to pharmacies for generic Medicaid prescriptions, including the definition of average manufacturer prices (AMPs) for use in calculating federal upper limit (FUL) reimbursements and the definition of a “multiple source drug.”

The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives outlined in an HHS report released last month, according to documents recently sent to Capitol Hill.

Key stakeholders are questioning why HHS' planning shop has moved to build an inventory of comparative effective research (CER) prior to the establishment of independent CER that was created under the health reform law.

As the Supreme Court prepares to examine whether medical product developers and life science firms must disclose all reported adverse events -- not only those situations with a confirmed link to a drug, device or dietary supplement -- to investors, a large swath of FDA-regulated industries are pressing the nation's top justices to reverse a lower court ruling that they say runs counter to a 1995 securities law aimed at reducing litigation.

Drug maker Allergan's decision to settle a years-long investigation into its off-label promotion of the popular medication Botox instead of pursuing its First Amendment lawsuit against FDA extinguished hopes from the pharmaceutical industry that resolution of the case would provide manufacturers with greater clarity on permitted discussions of unapproved uses.

In order to establish the impact and effectiveness of drug safety communications, FDA will query relevant stakeholders on how they use new information and plans to develop new metrics on this issue, an agency official said.

A pilot program to jointly inspect drug manufacturing facilities recently launched by FDA and its European Union counterpart could set the groundwork for further opening U.S. borders to drugs manufactured or stored abroad by harmonizing safety standards, sources said.

Even though FDA is still drafting its social media policy, the agency has already begun targeting advertising violations in this realm, which has resulted in at least one drug manufacturer warning its employees on what product information they are allowed to display on the Web in both a professional and personal capacity.

Mandating comparative effectiveness studies in premarket drug reviews could reduce the number of new pharmaceutical applications for products that are exhausting limited FDA review resources without providing substantive improvement over what has already been marketed, according to a prominent researcher with a history of provoking the drug industry on both safety and efficacy issues.

The focus of FDA's internal drug safety advisory panel has changed since its inception five years ago and is open to considering comparative safety, but not effectiveness, as part of its deliberations, agency officials said.

A new government plan to bolster medical countermeasures development and availability through conditional licenses, increased mid-pandemic data collection to guide approvals, an emphasis on cell-based vaccine technologies and by bolstering the work of small biotechnology firms could significantly boost the availability and manufacturing speed of therapies to respond to a pandemic, stakeholders said.

A federal judge's decision that a March 2009 Obama administration embryonic stem cell policy runs counter to federal law against destruction of human embryos has already resulted in calls for a legislative fix and spurred a top congressional lawmaker to call a hearing on the matter immediately after Labor Day.

HHS' Office of Inspector General is urging CMS to create a list of “less-than-effective” drugs and regularly send that list to health insurance companies, after finding that CMS spent $43 million on less-than-effective drugs over a two-year period.

A new report by AARP's Public Policy Institute, which concluded that prices for Medicare's most commonly used brand-named drugs dramatically increased in 2009, has prompted debate among several players in the health care sector.

FDA intends to take a huge leap into the realm of comparative effectiveness research within the next few weeks by officially contracting organizations to launch several initiatives to aggregate data on medical products, assess the information and eventually answer a myriad of questions on patient populations and class-wide issues, according to agency officials.

FDA plans to establish a new council that will focus on chemical and environmental science issues, which would help the agency modernize toxicology and risk assessments across several product categories, a top agency official said this week.

FDA is launching its first major nanotechnology initiative fueled by more than $7 million in the fiscal 2011 budget request, with plans to expand collaborative opportunities, train staff specifically on relevant issues and conduct research on characterizing nanomaterial safety and potency, agency officials said this week at an FDA Science Board meeting, although they declined to comment on specific regulatory approaches under internal deliberations.

FDA Commissioner Margaret Hamburg's first trip to China last week did not focus on a high-profile agency and congressional investigation into the contamination of a drug ingredient that resulted in dozens of deaths, an omission that could result in further lawmaker concerns that the U.S. and Chinese regulators are not working effectively to complete the probe, sources said.

FDA's precedent-setting decision this week to propose withdrawing approval of a drug cleared years ago under the condition that the pharmaceutical manufacturer would conduct post-market studies sends a warning to product makers to adhere to the terms of approval or risk facing enforcement action, industry sources said.