Jill Wechsler, Pharm Exec’s Washington Correspondent

A look at Medicare Part D drug plans and drug pricing and the plans of the current administration.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages of important medicines and in the duration of supply problems. Jill Wechsler reports.

Regulators, prosecutors shifting enforcement focus from off-label promotion to messages that raise safety issues, mislead.

Efforts intensify to bring outlays more in line with global trends.

Healthcare was the deciding issue for more than 40 percent of voters in the mid-term elections. Despite disagreement on most of the issues, leaders of the two parties are open to challenging the status quo on drug costs and spending.

Pharma says new "free-market" plan proposed by President Trump and HHS will harm patients. Jill Wechsler reports.

In publishing its proposed rule on disclosing drug prices just three weeks before the mid-term Congressional elections, it’s not a big stretch to see the move by the Trump administration as designed for short-term political purposes.

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

The regulator teams with other health agencies on strategies to combat antibiotic resistance, reshape R&D incentive schemes.

CDER director plans to start implementation of new review practices by the end of 2018.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to support innovative new medicines to combat infectious diseases.

With the rise in industry programs for developing biosimilars, tensions are high as innovator firms back strategies that appear designed to delay competition. Jill Wechsler reports.

To help combat the nation’s opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly.

New Action Plan aims to streamline development, but rebates and reimbursement block market access.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The Senate has approved several multi-agency budget bills for the coming fiscal year that boost funding for FDA and the NIH – and include a contentious provision that requires biopharma companies to disclose product prices in direct-to consumer advertising.

Just as biopharma companies are mastering the complexities of the five-year-old federal Open Payments program, state governments are enacting a host of additional marketing and disclosure rules and restrictions on industry interactions with health care professionals.

New Action Plan aims to streamline development, but rebates and reimbursement block market access.

Recent bipartisan efforts look to expand access for addiction treatment and stem inappropriate drug prescribing.

Scott Gottlieb is proposing to flatten out FDA’s structure by having Center directors report directly to him, giving more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs.

Rising pressure to access less expensive prescription medicines available overseas is prompting the Trump administration to explore flexible import policies, reports Jill Wechsler.

Streamlined clinical research, more guidance speed new cures to patients.

Jill Wechsler details recent bipartisan action to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution.

FDA has finalized a more flexible policy for how biopharma companies may discuss payments, outcomes and healthcare economic data with payers, formulary committees and other audiences with expertise in drug prescribing and coverage.

Azar and Gottlieb out front in revising rebates, restructuring Medicare, and promoting competition.

Legislators have requested that FDA do more to prevent drug shortages.

Pressure to assess and approve a growing volume of promising new drugs and biologics in accelerated timeframes is prompting a major reorganization of CDER's Office of New Drugs.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

After months of expectations and repeated delays, President Trump formally announced his strategy for making prescription medicines more affordable and accessible in the U.S.