Trump calls for federal lawsuit against opioid manufacturers | FDA OKs Teva's generic EpiPen | Orphan drug, rare pediatric disease statuses given to Wave's DMD therapy
August 17, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Trump calls for federal lawsuit against opioid manufacturers
President Donald Trump urged Attorney General Jeff Sessions to file a lawsuit against certain manufacturers of opioid painkillers and to take action against foreign companies, particularly in China. Trump didn't specify which companies he wants to sue, but a number of states have already filed cases against opioid makers such as Purdue Pharma, alleging they contributed to the opioid abuse crisis.
The Hill (8/16),  CNN (8/16) 
FDA OKs Teva's generic EpiPen
The FDA approved Teva Pharmaceutical Industries' generic version of Mylan's widely prescribed EpiPen allergy auto-injector for use in children and adults weighing more than 33 pounds. The drug, which is the first generic version of EpiPen, delivers epinephrine and is approved in 0.3 mg or 0.15 mg doses.
Healio (free registration) (8/16),  CNBC (8/16) 
Orphan drug, rare pediatric disease statuses given to Wave's DMD therapy
Wave Life Sciences' WVE-210201, being developed as a treatment for patients with Duchenne muscular dystrophy, received orphan drug and rare pediatric disease designations from the FDA.
Seeking Alpha (8/16) 
Eisai's unresectable hepatocellular carcinoma drug nabs FDA nod
Eisai's Lenvima, or lenvatinib, was approved by the FDA to treat patients with unresectable hepatocellular carcinoma in a first-line setting. The decision was backed by results from the REFLECT study, which showed statistically significant improvements in progression-free survival in patients when compared with sorafenib and Lenvima's noninferiority to sorafenib for overall survival, achieving a median overall survival of 13.6 months versus 12.3 months with sorafenib.
eMPR (8/16) 
Medical Devices
SPR Therapeutics' PNS systems win FDA clearance
SPR Therapeutics secured clearance from the FDA for its SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation systems for pain management. The platforms, which are indicated for use in the extremities or the back for up to 60 days to treat acute and chronic pain, enable two leads attached to a wearable pulse generator to be implanted by physicians during an outpatient procedure.
Medscape (free registration) (8/16) 
FDA announces 3 medtech development, safety initiatives
The FDA announced three initiatives as part of an effort to advance the development and safety of medical devices related to the current user fee reauthorization. The initiatives comprise releasing draft guidance on issuing certificates for devices exported from the US, establishing a summary reporting program to streamline device malfunction reporting and proposing a list of device accessories suitable for reclassification to Class I category.
AuntMinnie (free registration) (8/16) 
Food & Dietary Supplements
Report: Some baby foods contain "worrisome" amounts of heavy metals
Report: Some baby foods contain "worrisome" amounts of heavy metals
Sixty-eight percent of 50 packaged baby food products contained "worrisome" levels of one or more heavy metals such as inorganic arsenic, cadmium, lead and mercury, and 30% may be a "potential health risk" if consumed daily, while all products had at least one heavy metal, according to a Consumer Reports study. The report also showed higher levels of at least one heavy metal, especially inorganic arsenic, in products with sweet potatoes and rice, while organic food products had similar odds of containing heavy metals compared with nonorganic products.
ABC News (8/16),  The Cincinnati Enquirer (tiered subscription model) (8/16) 
Study examines cost-efficiency of FDA's teen smoking prevention campaign
Researchers found that the FDA's The Real Cost anti-smoking campaign prevented 175,941 at-risk adolescents ages 12 to 17 from becoming smokers from 2014 to 2016, yielding an estimated $31 billion in smoking-related cost savings. The findings were published in the American Journal of Preventive Medicine.
MM&M (8/16) 
Food and Drug Law Institute (FDLI) Highlights
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