Less than a month after approving a COVID-19 vaccine and with phase III trials just getting underway, the Russian Ministry of Health reported Sept. 8 that the first batch of its Sputnik V vaccine, or Gam-Covid-Vak, has been released for “civil circulation,” after passing the necessary quality tests at the Roszdravnadzor laboratories. While not specifying who would get those first doses, the ministry said, “the delivery of the first batches of vaccine to the regions is expected in the near future.”
The U.K.’s Medicines and Healthcare Products Regulatory Agency updated its guidance Sept. 7 on drugs that can’t be exported from the U.K. or hoarded. The list, first published in October 2019, now contains nearly 200 drugs, 85% of which were added to the list in 2020. All but a few of the 2020 additions were made in March and April as the COVID-19 pandemic took hold. That’s not to say all the drugs listed this year are due to the pandemic. For example, lithium carbonate, the most recent addition, is used to prevent cluster headaches and to treat manic-depressive disorder and other conditions.
The Biotechnology Innovation Organization (BIO) is urging companies and regulators involved in the development, approval, manufacture and distribution of COVID-19 therapies and vaccines to commit to principles essential to building public trust in those products. BIO outlined those principles in a Sept. 3 open letter, calling on the biopharmaceutical industry to conduct ethical clinical trials in accordance with best practices and to disclose important clinical data via well-respected scientific meetings or rigorous, independent peer-review journals. As for the FDA, BIO said the agency should maintain its historic independence, free from external influence, and it should ensure the appropriate use of new products is data-driven. The final principle BIO laid out is that “political considerations should be put aside by Republicans and Democrats alike.”
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending that the marketing authorizations for Gedeon Richter plc’s 5-mg Esmya (ulipristal acetate) and its generics to treat symptoms of uterine fibroids be revoked, as evidence shows the drug can cause serious liver damage. Approved in 2012 in the EU, Esmya was used for up to three months before women had surgery to remove the fibroids and later was approved for long-term use with treatment breaks in other women. Since it isn’t possible to identify which patients are most at risk of liver damage or to reduce that risk, the PRAC concluded the risks of Esmya outweighed its benefits. As a precautionary measure, the EMA suspended the use of the drug in March 2020, pending the outcome of the PRAC review. However, the recommendation does not affect the single-dose ulipristal acetate emergency contraceptive, marketed as Ellaone by Paris-based HRA Pharma SA and under other trade names. The EMA said there is no concern about liver damage with the single-dose formulations. Budapest-based Gedeon Richter said it expects the EMA will endorse the PRAC recommendation.
As several biopharma companies seek to police what they see as abuses of the 340B Drug Pricing Program, U.S. Rep. Frank Pallone (D-N.J.) chair of the House Energy and Commerce Committee, along with two subcommittee chairs, wrote to Health and Human Services Secretary Alex Azar last week, asking him to rein in the drug companies. The Sept. 3 letter acknowledged that under the law governing the 340B program, which requires drug companies to give qualifying hospitals and clinics steep discounts on certain outpatient drugs, manufacturers are permitted to audit the entities receiving the discounts. “However, there is no provision … which allows participating manufacturers to deny service to covered entities, or choose where covered entities may dispense the drugs they purchase,” according to the letter signed by Pallone and Reps. Diana DeGette (D-Colo.) and Anna Eshoo (D-Calif.). Several major drug companies have “taken issue with the expanded reach of contract pharmacies and have expressed concern about the potential for duplicate discounts,” the letter said. But their actions placing arbitrary limits on the number of contract pharmacies they’ll serve, cutting off the discounted 340B prices to contract pharmacies or imposing new reporting requirements on covered entities “are not oversight or compliance measures authorized by law, and could represent a failure of manufacturers to meet their requirements under the 340B statute,” according to the letter. The Energy and Commerce letter follows a similar letter that several hospital groups recently sent to Azar to complain about five major drug companies withholding the required discounts from contract pharmacies. In several congressional hearings on the 340B program, U.S. lawmakers have agreed that more oversight is needed in the program, which allows hospitals to use the profits they make from the discounted drugs however they see fit. But lawmakers have disagreed on the target of that oversight – the providers that benefit from the discounts or the drug companies themselves.
California Gov. Gavin Newsom signed an executive order Sept. 3 extending consumer protections against price gouging through March 4, 2021. Under state law, the governor’s March 4 proclamation of a state of emergency due to COVID-19 prohibited sellers of any kind from increasing prices by more than 10% for medical or emergency supplies, food, consumer goods and certain other items.
In a warning letter stemming from one of the last inspections the FDA conducted before the pandemic halted onsite inspections, the agency cited Calvin Scott & Co. Inc., of Albuquerque, N.M., for repackaging hydrochlorothiazide tablets, 25 mg, into heat-sealed pouches with one transparent side when the manufacturer’s container requires that the hypertension drug be dispensed in a “tight, light-resistant container.” Although the company recalled all the repackaged drugs, it didn’t address other vulnerabilities of the container-closure system with that particular drug. It also didn’t provide a stability protocol and data to evaluate if the expiration dates it assigned to the repackaged drugs were appropriate, according to the warning letter the FDA posted Sept. 8. The investigator also noted that the company repackaged various drug products on nondedicated repackaging lines, but it lacked cleaning validation studies to demonstrate that the cleaning procedures for that equipment adequately prevented cross-contamination. In addition, the company hadn’t established a quality unit independent of production duties. The FDA conducted the inspection March 9 through 12, just as it began halting its inspections due to the pandemic.
On a 3-1-1 vote, the U.S. Federal Trade Commission (FTC) approved a final order last week settling charges that North Chicago-based Abbvie Inc.’s $63 billion acquisition of Allergan plc, of Dublin, likely would result in substantial harm to current competition in the market for the treatment of exocrine pancreatic insufficiency (EPI) and would eliminate future direct competition in the market for IL-23 inhibitors, used to treat moderate to severe Crohn’s disease and moderate to severe ulcerative colitis. The final order requires Allergan’s EPI drugs, Zenpep (pancrelipase replacement therapy) and Viokase (pancrelipase), to be divested to Nestle SA, of Vevey, Switzerland. Allergan’s rights and assets related to brazikumab, an IL-23 inhibitor in development, are to be divested to Astrazeneca plc, of Cambridge, U.K. Commissioner Rohit Chopra voted against approving the final order and Commissioner Rebecca Kelly Slaughter didn’t participate in the vote, according to the FTC. Both Chopra and Kelly Slaughter, who are generally opposed to biopharma mergers, voted against the proposed consent order in May. At the time, Chopra called the acquisition an “unlawful takeover” and said the divesture to Nestle was “risky and concerning,” given that the company currently marketed no prescription drugs. He also objected to the divestiture to Astrazeneca, calling it a windfall.