Merck & Co. Inc. CEO Kenneth Frazier resigned from President Donald Trump's American Manufacturing Council. In his resignation statement, tweeted Monday by the Kenilworth, N.J.-based company, Frazier said, "America's leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal. As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism." The Merck tweet didn't reference a specific cause for the resignation, but it came two days after a protest by white supremacists in Charlottesville, Va., that turned deadly. The president's initial response to the violence was criticized because he didn't specifically call out white supremacy as the cause of the violence. Trump responded to the news of Frazier's resignation with a tweet about the CEO now having more time to "lower ripoff drug prices." Shortly after taking office in January, the president formed the advisory panel of CEOs from various manufacturing sectors as part of his Manufacturing Jobs Initiative. The biopharma sector was represented by Frazier and Johnson & Johnson CEO Alex Gorsky.

The International Trade Commission agreed to investigate a complaint filed last month by Bioverativ Therapeutics Inc., of Waltham, Mass., against CSL Behring LLC, of King of Prussia, Pa. The complaint alleged that CSL Behring is infringing claims in three of Bioverativ's U.S. patents with its import and sales of certain recombinant Factor IX products, according to a notice published in Monday's Federal Register.

The FDA is requesting comments about the abuse, medical usefulness and impact of scheduling changes on the medical availability of 17 drug substances, including cannabidiol, a schedule I cannabinoid in clinical trials for three indications; ketamine, a rapid-acting anesthetic used for short diagnostic and surgical procedures; pregabalin, an anticonvulsant used to manage neuropathic pain; and tramadol, a schedule IV opioid painkiller. Most of the other 13 drug substances have not been approved in the U.S. The FDA will consider the comments in preparing a response to the World Health Organization (WHO), which is determining whether to recommend that international restrictions be placed on the drugs. The WHO is expected to make its recommendations early next year, according to an FDA notice in Monday's Federal Register. Comments should be submitted by Sept. 13.

The FDA issued a guide Friday that takes doctors step-by-step through the process of requesting expanded access to an investigational drug for a single patient in a nonemergency situation. The guide includes links to the required form and a template for the letter of authorization from the drug sponsor. It also goes through the steps required for follow-up submissions, including safety reports, amendments and a summary of the expanded use.