Closing The Loop on Patient Engagement: Overcoming the PA Washout

Pharma brands invest heavily in sales and marketing tactics aimed at convincing physicians to prescribe their product. Even when successful, these efforts represent only a first step in realizing more prescriptions that actually get dispensed. Particularly when a prescription requires prior auth Powered by WPeMatico Continue reading Closing The Loop on Patient Engagement: Overcoming the PA Washout

FDA Launches Major Push for New Antimicrobials

The critical need for new medicines to combat infectious diseases that fail to respond to current medical treatment is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to suppor Powered by WPeMatico Continue reading FDA Launches Major Push for New Antimicrobials

States Expand Transparency & Disclosure Requirements

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 (HCPs). This stepped-up actio Powered by WPeMatico Continue reading States Expand Transparency & Disclosure Requirements

FDA Opens Door to Importing Scarce and Costly Drugs

For years, consumer advocates and state officials have pushed for access to less expensive prescription medicines available overseas, only to meet stiff resistance from FDA and government health authorities claiming that such action could bring unsafe and harmful products into the U.S. This oppo Powered by WPeMatico Continue reading FDA Opens Door to Importing Scarce and Costly Drugs

Gottlieb Reshapes FDA to Elevate Centers, Streamline Policymaking

Most FDA commissioners look to leave their imprint on the agency by making structural changes that update the roles and functions of lead operations. After more than a year at the agency s helm, Scott Gottlieb now proposes to flatten out FDA s structure by having the Center directors report dire Powered by WPeMatico Continue reading Gottlieb Reshapes FDA to Elevate Centers, Streamline Policymaking

Congress, Feds, FDA Take Action to Combat Opioid Crisis

The House recently enacted multiple legislative proposals to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution. This bipartisan action sets the stage for similar action by the Senate, as the legislators seek to address the deadly drug epi Powered by WPeMatico Continue reading Congress, Feds, FDA Take Action to Combat Opioid Crisis

FDA Clears Pathway for Off-Label Economic Communications

After years of debate and discussion, FDA has finalized a more flexible policy for how biopharmaceutical companies may discuss payments, outcomes and healthcare economic data with payers, formulary committees and other audiences with expertise in drug prescribing and coverage. By clarifying a sa Powered by WPeMatico Continue reading FDA Clears Pathway for Off-Label Economic Communications