Intellectual Property Provision In U.S.-Mexico Trade Deal Sets Off Alarms For Generics Companies, Consumer Groups
The provision in the trade pact would require a company to wait at least a decade before relying on data generated by a brand-name rival to then obtain regulatory approval and sell its own similar medicine. “The U.S. government is working in favor of the pharma lobby and against health,” said Peter Maybarduk, who heads the access to medicines campaign for Public Citizen. In other pharmaceutical news: Pfizer's problems at its manufacturing plant, digital pills, recalls and more.
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Trade Deal Between U.S. And Mexico Is Criticized For Allowing High Drug Prices To Continue
Although details of the new trade deal between the U.S. and Mexico have not yet been released, a fight is already brewing among some drug makers and consumer advocates over one provision. At issue is a sentence in a fact sheet that was released this week by the U.S. Trade Representative. A section concerning intellectual property noted there will be 10 years of data protection for biologic drugs and an “expanded scope” of products that will be eligible for protection, although the meaning of this last phrase was not fleshed out. (Silverman, 8/29)
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Pfizer Encounters Yet Another Setback At A Troubled Manufacturing Plant
Just one week after Pfizer hoped to resume full production at a manufacturing plant with long-standing quality control problems, the drug maker has had to hit the pause button on some activities due to “additional maintenance” that needs to be performed, according to a company spokesman. The setback is only the latest blow to Pfizer as it struggles to overhaul its troubled plant in McPherson, Kan., which has experienced a series of debilitating issues that have caused numerous product shortages and prompted ongoing concerns from regulators. (Silverman, 8/29)
Stat:
At $1,650 Per Month, The First Digital Pill Will Soon Roll Out To Certain Medicaid Patients With Mental Illness
The first digital pill will carry a price tag of $1,650 per month and soon be rolled out commercially to the first patients: people with mental illness covered by Medicaid, likely in regions including Florida and Virginia. The pill, sold by the drug maker Otsuka as Abilify MyCite, is embedded with a sensor that can alert a patient’s physician or caregiver after it’s been swallowed. Approved last November by the Food and Drug Administration for patients with schizophrenia and bipolar disorder, it’s a high-tech upgrade to the antipsychotic drug Abilify, which was first approved 16 years ago and has now gone generic. (Robbins, 8/30)
New Orleans Times-Picayune:
FDA Expands Recall Of Heart Drugs Containing Valsartan: Report
The U.S. Food and Drug Administration is expanding the list of recalled medications containing a substance called valsartan, used to treat heart failure and elevated blood pressure. The expanded list of recalled medications can be seen here. CNN reports that the initial recall occurred in July after lab tests revealed some medications with the active ingredient valsartan may have been tainted with a substance called NDMA, which is considered a carcinogen by the Environmental Protection Agency. The discovery has led to recalls in 22 other countries. (Clark, 8/29)
Miami Herald:
Massive Recall Of Nasal Mist, Baby Oral Gels Made For Chains
Three weeks after recalling one lot of one kind of nasal mist made for CVS for a microbial contamination, Product Quest Manufacturing expanded its recall to all lots of all nasal products and baby oral gels made at its Holly Hill, Florida, facility. This covers products sold by various companies and as the house brands for Walgreens, CVS, Meijer, Dollar General, Rexall, Family Dollar, Rite-Aid and Harmon. (Neal, 8/29)
Chicago Tribune:
New Illinois Law Prohibits Many Insurance Plans From Dropping Drug Coverage Midyear
A new Illinois law soon will prohibit insurance companies, in many cases, from yanking coverage for medications midyear. A measure signed into law by Gov. Bruce Rauner last week will limit the practice of so-called nonmedical switching — in which insurance companies stop covering a medication after consumers are already enrolled in a health plan. (Schencker, 8/29)
