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Many drugs granted accelerated approval by the U.S. Food and Drug Administration lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association...The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the usual amount of data has been collected to confirm their effectiveness and safety…Drugs granted Accelerated Approval should be rigorously evaluated using convincing patient-centered clinical outcomes in rigorous studies...we have found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards...For standard approval, the FDA generally requires gold-standard randomized controlled trials that demonstrate a drug’s safety and effectiveness. Fourteen (out 22 analyzed) of these accelerated approvals, however, were exclusively based on less-rigorous trials.

Food and Drug Administration advisers voted against approving a new opioid painkiller with a unique feature for deterring abuse: It releases a deep-blue dye if someone tries to get high by crushing, chewing or snorting pills...Panelists voted overwhelmingly against approving Intellipharmaceutics International's generic version of extended-release Oxycontin, a key drug in the U.S. opioid addiction epidemic. The FDA usually follows its advisers' advice...Doctors and scientists raised many concerns about the dye's safety for intended patients, and its effectiveness in deterring opioid abusers. Most said the company hadn't done enough studies of the drug...Some suggested blue stains around the mouth or nose from trying to abuse the drug could become popular among addicts. Others said the dye's "Scarlet Letter" shaming approach was insensitive...also...the company hadn't provided enough data to show that addicts couldn't find a way to convert the pills' active ingredient, oxycodone, into a liquid that could be injected...Advisers noted that the company hadn't studied issues such as whether the nasal irritant in the pill would prevent abusers from trying to snort it after crushing and whether the blood dye would discourage abuse attempts.

Endo International Plc agreed...to remove its long-acting opioid painkiller from the U.S. market to comply with the health regulator's request last month, sending its shares down as much as 3 percent...The U.S. Food and Drug Administration in June had requested the withdrawal of Endo's Opana ER, marking the first time the agency asked for an opioid painkiller to be taken off the market for public health reasons...The regulator's request followed the recommendation of an independent panel of advisers, which concluded that the drug's benefits no longer outweighed its risks...

...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...

The Senate...passed a bill allowing the Food and Drug Administration to continue collecting fees from drug companies to review new product applications...The FDA Reauthorization Act renews an existing law that expires on Sept. 30 and which provides the majority of FDA funds used to review pharmaceuticals and determine whether they are safe and effective. The Senate passed the bill by a vote of 94-1...It was passed last month in the House of Representatives.

Generic drug makers are turning to M&A to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices...Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale to an outright sale of the units...Mallinckrodt Plc, one of the largest producers of the generic opioid painkiller oxycodone, has been exploring a sale of its specialty generics unit…To bring down prices, the Food and Drug Administration has committed to eliminating the backlog of drug applications awaiting its approval. This could mean nearly 4,000 new medicines will come onto the market over the next several years, based on FDA estimates of drugs awaiting approval...Even before a potential flood of new products, small and mid-sized drug makers were under pressure as consolidation among generic drug distributors has made it less profitable for them to sell their drugs...A merger or a sale to a rival could alleviate some of the pressure through cost-cutting, reduced competition and new markets and products. It could also help companies negotiate better terms with drug distributors...

The...Food and Drug Administration moved...to prevent pharmaceutical companies from "gaming" the system to block or delay entry of generic rivals…FDA Commissioner Scott Gottlieb said...that the agency plans to hold a public meeting...to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition..."We know that sometimes our regulatory rules might be 'gamed' in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,"..."We are actively looking at ways our rules are being used and, in some cases, misused."...These obstacles can include limiting the availability of branded products for testing by generic companies, or prolonging negotiations with generic companies over the implementation of shared risk-management programs...

The Drug Enforcement Administration...proposed a 20 percent reduction in the manufacture of certain commonly prescribed opioid painkillers as well as other controlled substances for next year...The proposal comes as U.S. regulators and lawmakers take steps to limit the supply of opioids - a class of drugs that include prescription painkillers and heroin - to combat the epidemic of abuse, overdose and addiction...The DEA's proposed production quotas for Schedule I and II substances reflect the amount needed to meet the United States' medical, scientific, industrial, export and reserve requirements...The DEA recommendation comes about two months after the Food and Drug Administration took the rare step of asking a drugmaker (Endo International) to withdraw its opioid painkiller from the market, citing the public health crisis.

Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply...The...Food and Drug Administration outlined a proposal...to help integrate computer modeling and virtual testing as part of the regulatory approval process for manufacturers -- a step the agency said could save money while helping find cures for puzzling conditions such as Alzheimer’s disease...The average cost of developing a new medication is about $2.56 billion...and much of that goes to fulfilling the FDA’s rigorous demands for proving safety and effectiveness...The price of new technology affects the ability of people to access these new treatments...We therefore need to be mindful of the costs of our regulatory processes, to the degree that these costs also affect the availability of new innovations, and the way that they are ultimately priced…The idea of computer simulated experiments, sometimes called in silico trials, has been around for years but the FDA hasn’t provided guidance to allow the drug industry to use it in testing...The FDA has begun using computer modeling to build databases to help researchers predict how new treatments...will perform. And the agency is developing a family of "virtual patients" for testing new devices…

U.S. regulators have approved new competition for EpiPen, the emergency allergy medicine that made Mylan a poster child for pharmaceutical company greed...The Food and Drug Administration on Thursday approved Adamis Pharmaceuticals Corp.'s product, which should go on sale later this year...Symjepi is a syringe prefilled with the hormone epinephrine…Adamis says its product is easier to use than Mylan's EpiPen, a spring-loaded syringe filled with a set dose that comes with a training device...Symjepi also is smaller than EpiPen, so it's easier to fit in a pocket or purse. Most children and adults with severe food or insect allergies carry a device wherever they go and leave a spare at home, school or work...Just three years ago, EpiPens accounted for nearly 90 percent of both revenue and prescriptions filled in the U.S. for epinephrine injectors and syringes...In the first quarter of this year, brand-name EpiPens only drew about 60 percent of epinephrine device prescriptions, while generic EpiPens - mostly Mylan's - had captured 38 percent of prescriptions...