Author: Peter

United Nations...released a lengthy report that urges governments to take various steps to ensure greater access to needed medicines. And the list contains several proposals that have previously caused struggles with the pharmaceutical industry, suggesting the agency effort may be difficult to actually implement...Among the recommendations: the UN panel suggested countries should pursue compulsory licenses, which allow countries to sidestep patents and arrange for an alternative version of a medicine to become available...governments have shied away from pursuing licenses over concerns about repercussions…Consumer and patient advocacy groups largely praised the UN report. Doctors Without Borders...called it a "landmark report." But some complained that the panel did not go far enough in some ways...the UN should have "condemned trade agreements and national laws" that do not make clear that countries have the right to issue a compulsory license...The panel also said countries should require drug makers to disclose certain costs — such as R&D, production, and marketing…Another recommendation is for companies that receive public funds to publish their research findings...drug makers should make publicly available all anonymous patient data from completed and discontinued clinical trials...recommended data sharing and data access should be a condition for public grants for R&D.

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...

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 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.

California's attempt to curb drug prices, Proposition 61, could cause drug companies including Merck, Pfizer and Johnson & Johnson to raise prices, according to analysts, and the companies are already taken steps to block the bill's passage…According to analyst David Larsen...the major drug companies could choose to extend the prices they offer to the Department of Veterans Affairs to the state, while offsetting the discounts by raising the prices of other drugs...drug companies could risk a domino effect of having to discount other states...manufacturers could raise the prices they offer to the VA, which was threatened in 1992 when Congress considered doing something similar on a federal level...While drug companies stand to benefit politically from opposing this bill, they likely won't see an impact on their bottom lines if Proposition 61 passes - at least at first...Prop 61 addresses such a narrow portion of the California population - state agencies and non MCO Medi-Cal, the revenue and earnings exposure for the distributors and PBMs is minimal...likely that California's legislature will realize that companies can raise prices elsewhere, and will ultimately repeal the ballot measure.

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.'...

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:

1. Mylan has patent protection that lasts through 2025
2. There’s no room for error when you’re treating anaphylaxis
3. It doesn’t take an auto-injector to get epinephrine into the body — but it sure helps
4. The regulatory process is slow and expensive
5. The public hasn’t spoken (loud enough)

Generic drug prices in Medicare Part D decreased significantly in recent years, a new report from the U.S. Government Accountability Office says. So why the worry about price hikes? Hundreds of products saw “extraordinary price increases," that's why...For a group of 2,378 generic drugs--including those that entered or exited the market from 2010 to 2015--Medicare Part D prices fell overall by 59%...But “established generics"--the 1,441 drugs that stayed on the market the entire time--fell by just 22%. More than 300 cases of “extraordinary price increases” kept prices from falling further...Those extraordinary hikes amounted to at least 100%…The Generic Pharmaceutical Association is praising the newest GAO report. “At a time when everyone is looking for cost saving solutions, it is important to note that the GAO findings are consistent with the prevailing market trend--generic drug prices overall continue to decline year over year,”…

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...

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.