The Biosimilars Working Group, made up of diverse patient advocacy organizations, is speaking out against a decision by Canada's British Columbia provincial government to no longer cover Remicade (infliximab, Johnson & Johnson) in treating inflammatory bowel disease. Under phase 2 of the province's Biosimilars Initiative, patients have been given six months to switch to a biosimilar, either Pfizer Inc.'s Inflectra or Samsung Bioepis Co. Ltd.'s Renflexis. "The sweeping change in coverage is driven by the government's decision to generate significant health care savings from switching patients' medication rather than negotiating with the makers of the originator biologic to lower their prices," according to the working group. It said the cost-driven objective of the forced-switch policy, which likely will be applied to other biosimilars as they come to market, "fails to put physician wisdom, patient choice, appropriateness of care, accessibility and affordability at the forefront of health policy." Patients who are stable on a drug should not be forced to switch, the group said, pointing out that EU countries with successful biosimilar markets honor patient choice.
The FDA is opening a public docket for comments on the development and evaluation of abuse-deterrent formulations of central nervous system stimulants. The agency also wants to know whether such products could help address public health concerns related to prescription stimulant misuse and abuse. To date, the FDA has only approved abuse-deterrent formulations of opioid painkillers. The scope of misuse and abuse, illness and death is different for prescription opioids than for prescription stimulants, according to the agency. In opening the docket, the FDA said it is specifically seeking comment on associated harms and unintended consequences, including the risk of developing an addiction to the stimulants and transitioning to abuse of illicit stimulants or other substances.
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) drew a distinction Thursday between regulatory function and the clinical use of products in new guidance concerning the licensing status of bevacizumab (Avastin, Roche Holding AG) when it's compounded for intravitreal administration. The guidance is in response to the High Court's request for the agency to review whether the process of compounding bevacizumab exceeds what is permissible for off-label use. When prescribed or used by a health care professional, the compounded product does not create an unlicensed medicine, and it would come under the scope of off-label use, the MHRA said. But if the compounded drug were placed on the market, it would require a new or extended marketing authorization, or an exemption from the need for one, the agency added.
The MHRA issued a safety update Thursday on the use of Gilenya (fingolimod, Novartis AG) during pregnancy. The multiple sclerosis drug is associated with an increased risk of major congenital malformations – including cardiac, renal and musculoskeletal defects – when used during pregnancy, so women of childbearing potential must use effective contraception while on fingolimod and for two months after discontinuing the drug, the MHRA said.
The U.S. Senate Appropriations Committee approved a fiscal 2020 spending bill for agriculture, rural development and the FDA that provides the FDA with $3.148 billion in discretionary funding, a level that is $80 million over the fiscal 2019 enacted amount. The committee said the overall funding for the agency is expected to reach $5.76 billion in FY 2020, which includes user fees. Earlier this year, the appropriations committee in the House of Representatives charged with the FDA budget approved a budget authority of $3.254 billion for the FDA, to which user fees would be added, with $1.06 billion in drug user fees, $219 million in device user fees, $512 million in generic drug user fees and $39 million in user fees for biologics.