- Google, Sanofi launch joint diabetes venture (healthcareitnews.com)
The partners will develop a comprehensive diabetes platform and combine software, devices, medicine and professional care to improve diabetes management for patients...Verily Life Sciences, a subsidiary of Google’s parent company, Alphabet and Sanofi, a French multinational pharmaceutical company launched Onduo - a joint venture to improve diabetes care...The collaboration will leverage Verily’s miniaturized electronics, analytics and consumer software with Sanofi’s clinical expertise to create innovative treatments for diabetes patients…Onduo is designed to...help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine and professional care to enable simple and intelligent disease management...
- FDA staff flags concerns about Pfizer’s quit-smoking drug study (reuters.com)
Pfizer Inc's trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label...The FDA...expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug...Pfizer has been trying to have the "black box" warning - which warns of psychiatric risks including suicidal thoughts, hostility and agitation - removed from the drug's label...the study...compared Chantix or...Zyban with a placebo or a nicotine patch in smokers with and without a history of psychiatric disorders, showed that the drug did not significantly increase the incidence of serious neuropsychiatric side-effects...FDA staff disputed the results, flagging inconsistencies in data collection and characterization of the severity of some side-effects...
- Walgreens Will Divest Up To 1,000 Stores To Win Rite Aid Deal (forbes.com)
Walgreens Boots Alliance said U.S. antitrust regulators are requiring a divestiture of between 500 and 1,000 retail stores if its acquisition of Rite Aid will be approved...In the Walgreens-Rite Aid deal, it’s the Federal Trade Commission that is evaluating the transaction and demanding divestitures if the deal is going to win approval...Despite the large divestiture of stores, Walgreens expects the deal to still close in the second half of this year leaving the company with more than 11,700 U.S. stores. Walgreens has 8,200 U.S. stores and Rite Aid has 4,500. Even a divestiture of up to 1,000 stores would make Walgreens larger than CVS Health and its 9,600 pharmacies ...Walgreens chief executive officer Stefano Pessina has vowed to be a consolidator in a U.S. market he sees as facing more government control of pricing thanks in part to broader health coverage under the Affordable Care Act. The U.S. also has a growing population of aging baby boomers gaining Medicare coverage.
- Fixing Drug Pricing Means Paying For “Value” (theincidentaleconomist.com)
The way we pay for prescription drugs is more complex than the way we pay for anything else in the health system...When we pay for innovative medications...we’re not paying just for the pill – we’re paying a high price to incentivize the 10 years of clinical research needed to get that drug through the FDA approval process, and all the failures along the way. This high price is often negotiated down by various middlemen, but it nevertheless remains a "monopoly price." Patents, along with FDA-granted market exclusivity, preclude competitors from marketing the same drug under the same or different name for a period of time...the U.S. doesn’t have any national, price controls, profit controls, or other active or passive forms of across-the-board price regulation. This makes the American drug market unique, both in its strengths and weaknesses. Drug pricing reform should ideally protect those strengths while minimizing the weaknesses...
- Halloween Already? Big Pharma Marketers Try Terror Tactics to Scare Up Sales (adage.com)
Grandma as a menacing wolf. Parents whose carelessness leads to cancer in their kids. A teenager hospitalized after sharing a seemingly innocent kiss. Halloween may still be over a month away, but Big Pharma is already out to scare consumers...In recent months, several fear-instilling, often ominous commercials for medical devices, products and vaccines from drugmakers including Pfizer, GlaxoSmithKline and Mylan are airing in fairly heavy rotation…If you increase an individual's feeling that they're susceptible to a threat, and increase the perceived severity of that threat, people are more likely to take action...a trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine...Fear can be motivating until it's demotivating...There's a threshold at which we turn off and say, 'That's not me, that's someone else—my brain can't handle this level of risk and information.'...
- 5 reasons why no one has built a better EpiPen (statnews.com)
EpiPens just aren’t that great...They’re reliable, sure. They’ll buy a patient who’s in the midst of a severe allergic reaction a few crucial minutes to make his way to the hospital...But they’re also bulky. Their epinephrine solution isn’t particularly shelf-stable, and will easily degrade in temperatures that are too low or too high. They expire after about a year. And they’re not so user-friendly. Though EpiPens come with a practice kit, users in the midst of an allergy attack have mistaken which end’s the pointy end — and stabbed their thumbs instead of their thighs...But critics say Mylan has little incentive to improve EpiPens: “If you’re the monopolist, and you’ve got a product that expires every year, and it’s not super easy to carry around so the safest thing to do is have several tucked away in different places — I don’t see why there would be any pressure to innovate...Competitors have tried to make runs at the EpiPen...But it’s unclear if anything can displace the familiar auto-injector with the bright orange cap...Here’s why:
- Mylan has patent protection that lasts through 2025
- There’s no room for error when you’re treating anaphylaxis
- It doesn’t take an auto-injector to get epinephrine into the body — but it sure helps
- The regulatory process is slow and expensive
- The public hasn’t spoken (loud enough)
- Drug maker loses appeal of antitrust pay-to-delay case in Europe (statnews.com)
A European Commission court upheld an antitrust fine that was imposed three years ago against Lundbeck and four other drug makers for allegedly conspiring to delay the availability of a lower-cost generic version of an antidepressant...The ruling...came in response to an appeal of a 2013 decision that found Lundbeck and the generic drug makers pursued a pay-to-delay deal that violated European Union anticompetition regulations. The European Commission had fined the companies a total of $165 million with Lundbeck ordered to pay the bulk of the fine, or about $105 million...Regulators argue these deals are anticompetitive, force consumers to overpay for medicines, and escalate costs to the overall health care system. In the United States, the Federal Trade Commission estimates such deals cost Americans about $3.5 billion annually. Drug makers counter that the deals are not only legal, but allow lower-cost generic drugs to reach consumers faster than if patent litigation continued...
- Pharma suffers a setback in battle over Ohio drug pricing ballot measure (statnews.com)
An Ohio court has given a significant boost to a controversial ballot measure that is designed to lower the cost of medicines...In a ruling...the state Supreme Court decided that thousands of contested signatures on petitions submitted to the General Assembly were valid...The 4-to-3 decision capped months of procedural and legal skirmishes over the Ohio Drug Price Relief Act, which would require the state to pay no more for medicines than the US Department of Veterans Affairs...the ballot measure was opposed by the Pharmaceutical Research and Manufacturers of America...the Ohio Manufacturers Association, and the Ohio Chamber of Commerce. The groups contested the validity of signatures on a petition that had to be submitted to the general assembly as part of the state’s two-step process to place a measure on the ballot...Some statewide organizations and health care experts are concerned that the proposal, if enacted, is unworkable and will force a lengthy and complex litigation and bureaucratic quagmire...
- This Week in Managed Care: September 10, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.
- Food allergy group with ties to EpiPen maker says no to future donations (statnews.com)
A major food allergy advocacy group said this week that it would stop accepting donations immediately from drug companies selling epinephrine auto-injectors until there is “meaningful competition” in the market...While not mentioning Mylan by name, the statement from Food Allergy Research and Education implies that the EpiPen manufacturer is one of the targets. Mylan is the only one of FARE’s corporate sponsors that currently markets epinephrine auto-injectors. The organization...would not specify the exact amount of money that Mylan has donated to FARE, and the statement did not address how it would make up the lost donations...The organization has been actively involved in efforts across the country to expand access to epinephrine auto-injectors in public places like schools...