- The little-known FDA program that’s driving drug prices higher (latimes.com)
…Food and Drug Administration's unapproved-drugs initiative,...program is well known to some physicians and hospitals and their patients, who blame it for huge increases in the price of drugs that have been in common use for decades…it underscores an enormous flaw in our drug-approval process that rewards a few clever manufacturers at the expense of patients. The agency's unapproved-drugs initiative has laudable aims…to bring grandfathered medications that were in use before the FDA instituted rigorous testing requirements for safety and efficacy into line with modern standards…federal law also allows the FDA to incentivize drug research and development by granting marketing exclusivity to manufacturers who demonstrate a new use for a drug, or even a new dosing regime
- The Vernacular of Risk — Rethinking Direct-to-Consumer Advertising of Pharmaceuticals (nejm.org)
United States is the only country with a strong pharmaceutical regulatory infrastructure that allows direct-to-consumer advertising of prescription drugs in print, broadcast, and electronic media. U.S. consumers are accustomed to full-page ads in newspapers and magazines detailing a drug's benefits… That may soon change, however, as the Food and Drug Administration moves to enact new regulations regarding risk communication in DTCA…. responds to mounting research showing that reprinting highly technical package inserts in print ads does very little to communicate risks to consumers. The goal is to communicate those risks in a new vernacular.
- FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines (fda.gov)Clozapine Dispensing Requirements Changed (pharmacytimes.com)
Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about…severe neutropenia…There are two parts to the changes in the requirements for treating patients with clozapine. First, we have clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new, shared risk evaluation and mitigation strategy called the Clozapine REMS Program…
- Obama Nominates Duke Researcher Robert Califf to Lead FDA (bloomberg.com)
President Obama nominated Robert Califf as the next commissioner of the Food and Drug Administration,...Califf has been deputy FDA commissioner for medical products and tobacco. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization….
- FDA launches patient engagement committee (healthcareitnews.com)
Aims for a 'more patient-centered medical product development and assessment process'…As healthcare enters an era in which "patients and their care partners participate actively in decision-making and priority-setting," FDA has launched its first-ever Patient Engagement Advisory Committee…the group will offer perspective...on issues related to regulation of technology and medical devices, and their use by patients. FDA will learn about patient-related topics and better integrate those patient perspectives into its regulatory process.
- ‘Breakthrough’ drug may not mean what you think (reuters.com)
Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough,…FDA uses the term...for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims…the...Safety and Innovation Act (2012),..allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that "may demonstrate a substantial improvement over existing therapies"…"Breakthrough" is an aspirational term, chosen for the 2012 act to help expedite the new drug approval process,...
- Indian API maker Pan Drugs is reconstructing its manufacturing suite after holes in the wall and rusty equipment landed the facility a US FDA warning. (in-pharmatechnologist.com)
Pan Drugs received the Warning Letter…with the US Food and Drug Administration citing a number of deviations from GMP (good manufacturing practices) standards during an inspection of the Nandesari, Vadodara facility (India)…failed to maintain, repair, and keep clean its API manufacturing units,…holes in the walls and roof which allowed pigeons access near production equipment…gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building…We have given the commitment to stop all production while we renovate the facility,…
- Price fixing: PBMs push for lower prices of PCSK9 inhibitors (mmm-online.com)
Gilead Sciences' decision to slap Sovaldi,…with an $84,000 price tag was widely considered a turning point for payers and pharmacy benefit managers…the months leading up to the approvals this summer…negotiations were already under way between those drugmakers and Express Scripts,…PBMs are becoming increasingly savvy and hard-nosed about which drugs they will cover and what they are willing to pay for them… PBMs want to position [themselves] so they are advocating on behalf of their customers. Their customers are worried...
- Female Libido Pill Caused Dissent in FDA Ranks, Memo Shows (bloomberg.com)CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022526Orig1s000, SUMMARY REVIEW (accessdata.fda.gov)The Female Libido Pill and Five Other Drugs That Can Be Defeated by Their Own Side Effects (bloomberg.com)
At least three reviewers recommended against Addyi (flibanserin) approval..They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency… One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men… FDA had rejected the drug,…in 2010 and 2013 before approving it in August...
- Quarantine All Sterile Drugs from Compounder Medistat (pharmacytimes.com)FDA Announces Medistat RX’s Nationwide Voluntary Recall of Sterile Drug Products (fda.gov)
All non-expired drugs produced for sterile use by Alabama-based compounder Medistat RX have been recalled due to potential contamination, the FDA is warning pharmacists… recalled products were distributed nationwide between Nov. 1, 2014, and Sept. 3, 2015… FDA investigators and Alabama inspectors observed significant deficiencies that raised concerns about the compounder’s ability to assure the sterility of the drugs it produced.