Ohio proposes safety checkpoints for patients with chronic pain when their painkiller dose is increased; Sandoz's proposed rituximab biosimilar is rejected by the FDA; the White House is vetting 3 potential nominees with stronger political backgrounds for secretary of the Department of Veterans' Affairs.
Instead of setting limits on prescription opioids, Ohio Governor John Kasich, Republican, is proposing safety checkpoints to re-evaluate patients with chronic pain. According to The Plain Dealer, Kasich's new rule would call for doctors to look for signs of opioid misuse when patients are given larger doses of painkillers. Patients in hospice or with terminal conditions will not be included in the new rule, which is expected to take effect in the fall.
Sandoz has received a Complete Response Letter (CRL) from the FDA for its proposed rituximab biosimilar. The drug has been approved in Europe, marketed under the brand name Rixathan, and Sandoz hoped to gain approval for the 6 indications of the reference product, reported The Center for Biosimilars®. A CRL is used to communicate that FDA has reviewed a drug application, but decided it will not approve the drug for marketing in its present form.
After Rear Admiral Ronny Jackson, MD, pulled his nomination to be the secretary of the Department of Veterans’ Affairs (VA) amidst misconduct allegations, the White House has begun to vet 3 potential candidates. The Hill reported that former Republican Florida Representative Jeff Miller; Ron Nicol, a senior advisor at The Boston Consulting Group who helped manage the president’s transition; and acting VA Secretary Robert Wilkie are all being considered for the position. None of the candidates have been scheduled to meet with the president, who wants someone with a strong political background who can handle a tough confirmation.