- AbbVie buys special review voucher for $350 million (reuters.com)
AbbVie Inc has bought a (FDA) priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs…pediatric disease priority review voucher…eligible to have one of its drugs reviewed in six months, compared to the standard 10 months...AbbVie did not disclose its plans for the voucher...
- Kicking off the PDUFA VI Reauthorization Process (blogs.fda.gov)
Prescription Drug User Fee Act authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work...provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process...enables us to do more timely reviews of human drug applications….The current legislation, PDUFA V, is set to expire in September 2017…ideas for further enhancements, including:
- Further efforts to involve the patient perspective in drug development processes;
- Building on FDA’s Sentinel System for active surveillance of safety issues for medical products, including expanding its use as a source of data;
- Enhancing regulatory science initiatives, including the use of patient-reported outcomes and biomarkers.
- Drug execs behind female libido pill have run afoul of FDA (apnews.myway.com)
small drugmaker…may succeed…in winning approval for the first drug to boost women's sexual desire…team that founded Sprout Pharmaceuticals is not new to the..business …previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet.. ran afoul of federal rules,… FDA sent Slate an 11-page warning letter…"I can't remember seeing a warning letter with so many examples of misbranding in it," said Fugh-Berman, who … signed a petition urging the FDA to reject Addyi (flibanserin)
- Kim Kardashian, Dr. Oz And TV Drug Ads (forbes.com)
Data show that these ads certainly increase the sales of an advertised drug… these ads also tend to trigger a negative response from the public, This use of drug promotion via social media is far more dangerous than TV drug ads. Getting celebrities with millions of followers to tout your product,…can have a big impact… FDA needs to crack down on this as vigorously as it does other forms of drug promotion....
- FDA approves first treatment for sexual desire disorder (fda.gov)Approved Risk Evaluation and Mitigation Strategies (REMS) (accessdata.fda.gov)
Addyi is being approved with a risk evaluation and mitigation strategy, which includes elements to assure safe use…because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol…REMS requires that prescribers be certified… Additionally, pharmacies must be certified…Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber...
- FDA approves use of opioid painkiller in 11-16 year olds (reuters.com)CDER Conversation: Pediatric pain management options (fda.gov)
Food and Drug Administration has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives….warnings and precautions for pediatric patients are the same as those for adults...
- KemPharm spikes as its anti-abuse pain drug rolls toward the FDA (fiercebiotech.com)
KemPharm, at work on an abuse-deterrent formulation of hydrocodone, said its lead drug performed well in a study designed to determine how easily the pill can be ground up and snorted… human abuse liability (HAL) trial.. 36% less exposure to the active ingredient… shares rose about 18% on the announcement...
- F.D.A. Approves Addyi, a Libido Pill for Women (nytimes.com)FDA approves first treatment for sexual desire disorder (fda.gov)
first prescription drug to enhance women’s sexual drive won regulatory approval …victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women…Addyi (flibanserin) — is actually the first drug approved to treat a flagging or absent libido for either sex. Advocates who pressed for approval…Even the Score, said that a drug to improve women’s sex lives was long overdue… National Consumers League..the campaign behind Addyi … made a mockery of the system that regulates pharmaceuticals..
- Raleigh’s Sprout Pharmaceuticals awaits FDA ruling on female libido drug (newsobserver.com)
Sprout Pharmaceuticals is a small drug company with a potentially very big drug – the world’s first pill to boost women’s sex drive….Food and Drug Administration is expected to announce Tuesday whether it has approved Sprout’s drug, Addyi (flibanserin), ..plans to market as the "little pink pill"… Interest in Sprout’s libido pill is expected to run so high that, to curb potential misuse, Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.
- FDA Endorses Safety Device for Kids’ Liquid Medications (medpagetoday.com)How safe is your baby’s medicine bottle? (consumerreports.org)
Flow restrictor on bottle necks helps prevent children from overdosing..Food and Drug Administration has endorsed the use of a safety device for bottles of children's medication containing liquid acetaminophen,…Called a flow restrictor, the device fits into the top of a bottle to prevent kids from inadvertently squeezing or sucking out too much liquid..