Just four months before insulin products that were approved in the U.S. with new drug applications are deemed to be approved under biologic license applications, the FDA Monday released a draft guidance to help guide efficient development of biosimilars and interchangeables referencing those drugs by clarifying what data and information may be necessary. Addressing clinical immunogenicity considerations, the draft spells out certain circumstances in which a comparative clinical immunogenicity study wouldn’t be necessary for some biosimilar and interchangeable insulin products. “In the circumstances described in the draft guidance, the FDA generally expects the risk of clinical impact from immunogenicity to be minimal for certain proposed biosimilar and interchangeable insulin products,” Acting FDA Commissioner Brett Giroir said. However, those products would still need an immunogenicity assessment that could include a scientific justification of why a comparative clinical immunogenicity study isn’t needed. The recommendations in the draft guidance “could ultimately bring biosimilar or interchangeable insulin products to the market more quickly,” Giroir said, adding that the resulting competition should improve patient access to the drugs. Comments on the draft should be submitted by Feb. 25.
The FDA released a draft guidance describing its implementation of revised provisions for requesting and issuing a certificate of confidentiality, which is intended to protect the privacy of human research participants. Historically, the certificate generally protected researchers from being compelled to disclose identifiable and sensitive information about research participants. The 21st Century Cures Act broadened the protections by prohibiting certificate holders from disclosing the information unless a specific exception applies. Comments on the draft should be submitted by Jan. 9.
The Centers for Medicare & Medicaid Services (CMS) is once again delaying the inclusion of U.S. territories in the Medicaid Drug Rebate Program (MDRP). CMS issued a second interim final rule delaying the inclusion until April 1, 2022. In announcing the new delay, CMS said only one territory would be prepared to implement the MDRP by April 1, 2020 – the date set in the first interim rule, which extended the original deadline of April 1, 2017. While the territories work to prepare the systems needed to participate in the MDRP, they can continue to negotiate Medicaid pricing independently with drug manufacturers. Besides providing the territories more time, the delay will give manufacturers two more years to change their government pricing systems to begin including drug sales in the territories in their average manufacturer price and best price calculations. It also will likely delay incentives manufacturers may have to make regarding possible changes to drug prices in the territories, according to CMS. The comment period on the interim final rule ends Jan. 24.
Following rare fatal reactions, the U.K. Commission on Human Medicines (CHM) is recommending stronger measures to minimize the risk of using a yellow fever vaccine. While the vaccine’s benefit-risk profile remains favorable for most people, CHM advised that further precautions be taken in people with weakened immunity and those ages 60 or older. Older people “should only receive the vaccine if there is a significant and unavoidable risk of yellow fever infection during their travel,” said Philip Bryan, vaccine safety lead at the Medicines and Healthcare Products Regulatory Agency.
The Accelerating Medicines Partnership program for Parkinson’s disease (AMP PD) launched a data portal to provide de-identified information collected from more than 4,000 patients and healthy controls to researchers working to develop therapies for the disease. The portal enables researchers to study complex datasets and perform genome-wide analyses at a scale previously impossible, according to the NIH. AMP PD is a partnership between the NIH, FDA, The Michael J. Fox Foundation for Parkinson’s Research and industry participants, including Celgene Corp., Glaxosmithkline plc, Pfizer Inc., Sanofi SA and Verily Life Sciences. The goal of the partnership is to transform and accelerate drug development in Parkinson’s by helping to determine which biomarkers show the greatest potential for predicting the disease and its progression.
Kenneth Sun, a doctor who practiced in Pennsylvania and New Jersey, pleaded guilty last week to participating in a scheme that involved more than $140,000 in bribes and kickbacks from Insys Therapeutics Inc., of Phoenix, in exchange for prescribing Subsys, a sublingual fentanyl spray approved by the FDA in 2012 for the treatment of breakthrough pain in cancer patients. According to the U.S. Department of Justice, Sun admitted that he prescribed the potent opioid when it was medically unnecessary, not eligible for insurance reimbursement and considered unsafe. Sun said the payments he received from Insys were disguised as honoraria for sham educational presentations about Subsys, some of which he didn’t attend. He also admitted that he caused Medicare to pay more than $847,000 for Subsys prescriptions that were medically unnecessary and not eligible for Medicare reimbursement.