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The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers...FDA Commissioner Scott Gottlieb, M.D...announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it...“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”...The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur...the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses...

The US Food and Drug Administration's Center for Biologics Evaluation and Research...announced it is launching a new program for early meetings with biologics developers...The new program, called INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER ProducTs), replaces CBER's existing pre-investigational new drug meeting program...We know that academic investigators, small and medium enterprises, and sometimes even large companies can have questions regarding the path from preclinical to clinical development for biological products—particularly those that raise new regulatory questions," said CBER Director Peter Marks...the new program will be better tailored to providing input to biologics developers at early stages of development and will help sponsors plan their development programs to gather evidence needed for FDA approval more effectively.

• Lower drug prices for older people
• Persuade other countries to pay more
• Require drug ads to include the price
• Ban ‘gag clauses’ for pharmacists
• End the patent games
• On the horizon

The governor’s task force on the opioid crisis met for the second time...to receive a progress report on its efforts to rein in abuse and death resulting from prescription painkillers...Representatives of health care organizations and Nevada officials told members of the Governor’s Opioid State Action Accountability Task Force that progress was being made on four priorities identified by the panel at its first meeting...: prescriber education, treatment options, data collection and criminal justice interventions...Specifics included obtaining federal funding for three new treatment centers; development of informational presentations for schools and law enforcement; distribution of the opioid reversal drug naloxone to law enforcement; and creation of the Opioid Dashboard, a publicly available collection of state data related to the epidemic...At the task force’s third meeting in July, presenters promised to present updates on other task force goals, including identifying ways to compile real-time overdose data...

The Food and Drug Administration is advising consumers not to purchase or use Maximum Powerful, a product promoted for sexual enhancement that contains sildenafil, the active ingredient in Viagra. This product was identified during an examination of international mail shipments...The announcement is part of the agency’s effort to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. The culprit products are typically promoted for sexual enhancement, weight loss, and bodybuilding and are often represented as being “all natural.”...the FDA noted that it is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. As a result, the agency issued a blanket warning that consumers should exercise caution before purchasing any product touted as improving sexual enhancement, helping with weight loss, or building up muscle...

The National Institutes of Health is explaining how it will spend $500 million in research funds Congress appropriated to address the current opioid crisis...The list of objectives, published...in the Journal of the American Medical Association, includes: developing new medications to treat opioid addiction; tinkering with existing medications so they can be taken less often; improving medicines that reverse overdoses; developing new models of caring for people with opioid addiction in the healthcare and criminal justice systems; determining the best way to care for newborns in opioid withdrawal; discovering and validating new targets for non-addictive pain drugs and devices, and partnering with pharmaceutical companies to accelerate new pain and addiction medications. The $500 million will be distributed as research grants after a call for proposals later this summer.

...FDA’s Center for Drug Evaluation and Research released its second annual Drug Safety Priorities report, which details drug safety initiatives carried out by CDER and FDA. The report highlights drug safety program milestones and gives an update on goals achieved in 2017. Efforts by FDA to ensure drug safety science, surveillance, and oversight are discussed...Detailed in the report are the agency’s efforts on pharmacovigilance, medication errors, and risk management...The report also goes into detail about the agency’s views on how real-world evidence can advance drug safety. An update on the agency’s efforts to combat the opioid crises is also provided...

The Food and Drug Administration approved the medication, called Epidiolex (cannabidiol), to treat two rare forms of epilepsy (Lennox-Gastaut Syndrome and Dravet Syndrome) that begin in childhood. But it's not quite medical marijuana...British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis...FDA officials said the drug reduced seizures when combined with older epilepsy drugs...The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV...Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana...it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect...Physicians say it's important to have a consistent, government-regulated version...

...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.

Drugmakers may not be the only ones keeping less-expensive drugs off the market...The Food and Drug Administration has approved nine biosimilars, generic versions of biologic medicines, but only three are available...Manufacturers are using several schemes to "hamstring biosimilar competition," FDA Commissioner Scott Gottlieb said... he worries pharmacy benefit managers have been "complacent participants" in the schemes...PBMs and insurers may stick with branded biologics because they receive discounts from manufacturers on these treatments. That can leave consumers paying for costly treatments when less-expensive ones are available while PBMs make more money on these discounts, known as rebates...Many of these practices persist because high list prices enable lucrative returns across the drug supply chain as the spread between list and net price is carved up and shared among participants...he (Gottlieb) applauded insurers who have recently pledged to pass manufacturer's drug rebates directly on to some of their members...This is a bold action that will help create a fairer, more transparent market...I hope that other insurers, employers, and manufacturers follow their lead. I also hope that your industry will continue to innovate to make it more transparent to pass along these rebates...