FDA reaches agreement with generics industry on new GDUFA commitments
WASHINGTON — The Food and Drug Administration and the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers and contract manufacturing organizations — have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.
“GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments," stated David Gaugh, SVP sciences and regulatory affairs, GPhA. "The commitments outlined in GDUFA II enable the FDA to continue delivering on its promise to protect public health by ensuring access to safe and effective generic medicines."
“The PBOA hails the successful conclusion of the GDUFA II negotiation, and we believe that industry, the FDA and patients will see great benefits from the program during the next five-year period," added Gil Roth, president Pharma & Biopharma Outsourcing Association. "PBOA’s presence at the negotiating table ensured that Contract Manufacturing Organizations were represented in the new iteration of this critical program.”
The generics industry is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs to assure that no submissions from GDUFA I are left behind. It will also provide the FDA with additional resources, improving transparency and accountability in order to enhance the ability of the FDA to meet GDUFA II goals. Process changes and staff additions have been positive steps thus far, and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals.
GDUFA I was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act with the goals of improving safety, access and transparency within the generic sector. The new version of this industry-funded program, includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications (ANDAs), enhance FDA’s inspection infrastructure and increase accountability, while providing relief for small businesses.
FDA warns against combined use of opioids and benzodiazepines
SILVER SPRING, Md. – The U.S. Food and Drug Administration announced Wednesday that it is requiring class-wide changes to drug labeling, including patient information, for almost 400 products to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” stated FDA Commissioner Robert Califf. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.”
Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products and benzodiazepines with information about the serious risks associated with using these medications at the same time.
Risks include extreme sleepiness, respiratory depression, coma and death. Today’s actions are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.
Given the importance of reaching health care professionals and the public with information about the risks of using these products together, today the FDA also issued a Drug Safety Communication. Through the Drug Safety Communication and by requiring patient Medication Guides, the agency also provides information for anyone who is taking, or who knows someone taking, either of these types of medications and encourages them to better understand the risks of taking them together; and, when it is medically necessary, for health care providers to be careful to prescribe them as directed, without increasing the dose or dosing frequency for either drug.
Opioid analgesics are pain-reducing medications that include prescription oxycodone, hydrocodone, and morphine, among other drugs, under both brand and generic names. Certain other opioid medications are also approved to treat cough.
Benzodiazepines are drugs typically prescribed for the treatment of neurological and/or psychological conditions, including anxiety, insomnia and seizure disorders. Both classes of drugs depress the central nervous system (“CNS depressants”); however, each has unique pharmacology, safety risks, and labeling information related to its use.
Therefore, the FDA is requiring opioid analgesics, prescription opioid cough products and benzodiazepines to have slightly different labeling. Additionally, due to the unique medical needs and benefit/risk considerations for patients undergoing medication-assisted therapy treatment to treat opioid addiction and dependence, the FDA is continuing to examine available evidence regarding the use of benzodiazepines and opioids used as part of MAT.
The FDA’s data review showed that physicians have been increasingly prescribing them together, and this has been associated with adverse outcomes. The number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41% between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.