House and Senate staff have been working on a bipartisan, bicameral basis throughout August recess to come to an agreement on drug compounding legislation, and stakeholders said they are encouraged by the continued focus on the issue.

A working group of drug companies and patient advocates, led by former HHS chief Tommy Thompson and a former FDA staffer, are urging lawmakers to impose stricter limits on office use drug compounding than those included in a Senate proposal and to require documentation of patients' need for modified FDA-approved drugs, according to compounding policy recommendations floated this week.

Starting in November WellPoint will only cover compounded drugs that contain an FDA-approved product, making the insurer the third to tweak its policy since the practice of compounding has garnered nationwide attention, although the company attributes the stepped-up enforcement to Health Insurance Portability and Accountability Act changes.

FDA and other agencies will likely receive flat funding under a short-term spending measure that pushes the budget fight into the fall, as Congress turns its attention next week toward the possibility of intervening in Syria, sources said.

FDA laid out efforts to gather more data about the effectiveness of long-term opioid use for non-cancer, chronic pain during a recent closed door meeting with researchers and drug company representatives, but these efforts could stall from a lack of funding and other research challenges, meeting attendees said.

Two biopharmaceutical companies are pointing to the development of opioids with new molecular structures as the next step in getting more abuse-deterrent products on the market, although FDA has not yet indicated how it would measure the safety and effectiveness of such products.

Strategies that have allowed a substantial number of cancer drugs to qualify for the new breakthrough designation could be used by sponsors developing drugs in other disease areas to speed up their own development programs, investor and cancer research sources said.

Early notification procedures have helped prevent new medication shortages, but the number of ongoing drug shortages has not fallen because quality manufacturing problems persist, pharmacy and hospital sources said.

An FDA Safety and Innovation Act-mandated analysis laying out evidence showing how women and other patient subgroups are being underrepresented in clinical trials provides baseline information to support further administrative action, patient advocates said.

An attorney's analysis of FDA's previous accelerated and fast track drug approvals shows that the strength of clinical evidence necessary for approval varies and many drugs approved via the expedited pathway initially showed little or no clinical benefit.

The Generic Pharmaceutical Association is urging California Gov. Jerry Brown (D) to veto a biosimilar substitution bill that easily passed the state Senate this week. Groups on both sides of the issue are touting support for their positions as California stands to become the fifth state to enact a law requiring physician notification when a biosimilar is dispensed.

Heidi Wilson, a former GOP congressional staffer, has been named director of federal government affairs at the Generic Pharmaceutical Association, the group said Tuesday (Sept. 3). The move comes as GPhA works to increase generic utilization and fight attempts to limit patent settlements, among other issues.

Pharmacists and some Medicare beneficiaries are pushing for more signatures on a bill that would let retail community pharmacies deliver diabetic testing supplies to Medicare beneficiaries.

Industry experts say a CMS proposed Part D rule expected within the next few weeks could address agency concerns that some preferred pharmacy networks cost Medicare more than other pharmacies.

Patent settlements where a brand company has agreed not to market an authorized generic are likely to be the next battleground in the so-called "pay for delay" fight as courts grapple with interpreting the Supreme Court's recent decision in FTC v. Actavis, court watchers said.