As the next step toward mandatory reporting of drug shortages, Health Canada is seeking proposals to develop and maintain a central website for drug companies to publicly report shortages and discontinuations. The new website will replace drugshortages.ca, an industry-run site based on voluntary reporting. When completed, the new site will include better notification features, a mobile application and information for providers and patients. Meanwhile, Health Canada is working with players from across the drug supply chain to finalize regulations that would require drug companies to report potential supply disruptions. The regulations are expected to be finalized within a few months.
Amid continuing controversy over a generic drug labeling rule proposed in 2013, the FDA is once again delaying action on the rule – this time until next April. The rule would allow generic drug companies, like their brand counterparts, to independently update their labeling with new safety information before the FDA reviews the change. If finalized, the rule would end the Supreme Court-recognized preemption that protects generic drugmakers from state tort claims. Several U.S. lawmakers have joined the generics industry in fighting the rule. The latest postponement shows "the FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety," according to Public Citizen, a government watchdog that petitioned the agency in 2011 to make the rule. "At this point, we worry about the agency's commitment to finalizing the rule, which it acknowledged in 2013 would improve drug safety." (See BioWorld Today, Nov. 12, 2013.)
A review of antimicrobial resistance commissioned by the U.K. prime minister called for a concerted global effort to tackle the problem and made several recommendations, including a $2 billion endowed Global Innovation Fund to support early stage research for novel antibiotics, diagnostics and vaccines. The review also called for innovative ways to reward companies for bringing a new antibiotic to market while discouraging unnecessary use of the drug. One suggestion was a $1 billion market entry reward, funded by several countries and the biopharma industry. In addition, the report recommended that leading countries make it mandatory by 2020 that antibiotic prescriptions be based on diagnostic test results. Such a measure would encourage the development of rapid diagnostics, the review team said.
The HIV Vaccine Trials Network, funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), plans to advance an experimental HIV vaccine regimen into a pivotal phase IIb/III trial in South Africa in November, enrolling 5,400 men and women, ages 18 to 35, who are at risk for HIV infection. Results from the study, HVTN 702, are expected in late 2020. The regimen is designed to provide greater protection than that tested in the 2009 RV144 trial in Thailand, and it has been adapted to the predominant HIV subtype in southern Africa. The vaccine regimen in RV144 was found to be 31.2 percent effective at preventing HIV infection during the 3.5 years after vaccination and 60 percent effective one year after vaccination, according to NIAID. The HVTN 702 regimen consists of two experimental vaccines: ALVAC-HIV, a canarypox-based vaccine from Sanofi SA, of Paris, and London-based Glaxosmithkline plc's bivalent gp120 protein subunit vaccine with an adjuvant that enhances the body's immune response to the vaccine. The randomized, placebo-controlled HVTN 702 trial will include booster shots at the one-year mark.
The FDA updated a 2007 draft guidance to help sponsors design a clinical development program for drugs to treat chronic obstructive pulmonary disease. Recognizing the importance of assessing patient perspectives in clinical trials, the FDA added the St. George's Respiratory Questionnaire to the draft as a patient-reported outcome tool. The agency specifically is seeking comments on use of the questionnaire, along with comments on the rest of the guidance, given how much the landscape of clinical trials has evolved since 2007. Comments are due by July 19.
The FDA is reiterating a safety warning it made in 2013 when it removed two indications for ketoconazole oral tablets. Because of the risk of serious liver damage, adrenal gland problems and harmful interactions with other drugs, the agency removed treatment of skin and nail fungal infections from the label, saying the risk outweighed the benefit in those indications. However, the agency said Thursday a physician survey showed that in the 18 months ending in June 2015, skin and nail fungal infections were the only diagnoses for which doctors prescribed the antifungal drug. Since the 2013 labeling change, the FDA has received one report of a patient death due to liver failure associated with oral ketoconazole prescribed to treat a fungal nail infection.
In another safety matter, the FDA is investigating interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations in patients treated with the diabetes drug canagliflozin (Invokana/Invokamet, Janssen Pharmaceuticals Inc.). Although the agency hasn't determined whether canagliflozin increases the risk of amputations, it is encouraging patients who are taking the drug to notify their doctor if they experience new pain or tenderness, sores or ulcers, or infections in their legs or feet.