Rx Drugs

The new trade deal between the United States, Canada and Mexico gives makers of brand biologics 10 years of data exclusivity, even though Canadian law grants eight years of protection, and the deal includes a “robust scope of product eligibility for protection,” according to a summary from the U.S. Trade Representative Office.

FDA on Friday (Sept. 28) issued two draft guidances that agency chief Scott Gottlieb says will lower the cost of drug development, making it easier for sponsors to bring second and third drugs in a class to market.

The Drug Enforcement Administration has placed the first FDA-approved cannabidiol (CBD) drug, Epidiolex, under Schedule V of the Controlled Substances Act, and manufacturer GW Pharmaceuticals says the drug should be available in the next six weeks.

HHS on Friday (Sep. 28) announced about $2.6 million in prize money for the KidneyX: Redesign Dialysis competition, and Ed Simcox, HHS chief technology officer, said at a briefing that the while the prize competition can encourage innovation, coordination between FDA and CMS to improve patient access will also be part of the KidneyX initiative.

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

The final opioid legislation unveiled by House and Senate negotiators late Tuesday (Sept. 25) includes two controversial provisions -- one expanding Medicaid payments for opioid-abuse treatment in large inpatient facilities and another allowing non-physician providers to prescribe a drug used to treat opioid addiction.

The opioid legislation hammered out by House and Senate conferees includes a requirement that HHS, in consultation with FDA and other relevant agencies, develop materials describing the circumstances under which a pharmacist may decline to fill a prescription for a controlled substance.

The Trump administration has proposed a rule that would allow the government to deny green cards for immigrants who receive Medicare Part D low-income subsidies or Medicaid, but, in a departure from leaked drafts, the proposal wouldn’t target immigrants who receive Affordable Care Act subsidies.

Senate Minority Leader Chuck Schumer (D-NY) is the key lawmaker in brand drug makers’ play to get Congress to lower their share of seniors’ drug costs, sources on both sides of the lobbying effort say.