Author: Peter

The Federal Trade Commission...accused a Shire plc subsidiary of filing dozens of "sham" petitions with the Food and Drug Administration in an effort to delay generic competition to its branded prescription drug Vancocin HCI...the FTC alleged that Shire ViroPharma filed 43 citizen petitions with the FDA (along with 3 lawsuits) over a seven-year period, knowing that the FDA typically waited to approve generic drugs until it had resolved any outstanding citizen petitions...a deliberate attempt to maintain a monopoly...ViroPharma’s efforts led consumers and other purchasers to pay hundreds of millions of dollars more for the drug.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

...House of Representatives subcommittee will take up bipartisan legislation next week to foster generic drug development…President (Donald) Trump made it clear...he wants competition to lower drug prices, and that is precisely what this measure will help accomplish...Specifically the bill will require FDA to prioritize, expedite and review generic applications of drug products that are currently in shortage, or where there are few manufacturers on the market...the bill would also increase transparency around the backlog of generic drug applications at the FDA, saying there was an "unacceptably high" number...

Pharma companies sat out the Super Bowl this year after last year’s intense scrutiny—and criticism—of three ads that aired. But their DTC devices did make one appearance...The Twentieth Century Fox movie trailer for "A Cure for Wellness" parodied a pharma ad, mashing up formulaic imagery from happy couples on the beach to a Tai Chi class in the park. But as the 30-second ad played out, it became apparent that the familiar litany of voiceover side effects was part of a much more sinister twist. (The horror movie is about a man who goes to a "wellness spa" in the Swiss Alps in search of his boss and finds that it is anything but.)...While the past couple of years have seen at least one pharma ad in the Super Bowl, increasing pressure from politicians and consumers about pricing issues may have companies laying low. That pressure, along with last year’s backlash, was likely enough to convince pharma to stay home this year, although the $5 million per 30-second spot price tag may have also been a factor.

Pharmacy benefit managers — the middlemen in drug price negotiations — have been under siege since Donald Trump was elected last fall and vowed to go after rising drug costs...The pharmacy benefit management industry is prepared to fight back against the criticism and any possible regulations. But here's the political challenge: It's going to have a tough time explaining the value of its companies to the public, especially since their business model relies on secrecy and that consumers have little knowledge of what pharmacy benefit managers are...Most of the furor over drug prices has focused on the manufacturers that create the prices. But the increased scrutiny of the byzantine drug supply chain has landed heavily on pharmacy benefit managers that serve as intermediaries between drug makers and health insurers and employers…

Brian Haug, President of Pharmacy and Managed Markets, Pharmacy Times (PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more.

The New York Times recently published the list of the 200 highest paid CEOs in the U.S. as pulled together by Equilar, a leading provider of board intelligence solutions. Let’s take a look at the top five biopharma CEOs on that list.

1. Leonard Schleifer, Regeneron Pharmaceuticals. ranked #7, with $47.5 million in total compensation.
2. Jeffery Leiden, Vertex Pharmaceuticals, ranked #20 with $28.1 million in total compensation
3. Robert Hugin, Celgene , ranked #36 with $22.5 million
4. Brent Saunders, Allergan ,ranked #43 with a total compensation of $21.6 million.
5. Alex Gorsky, Johnson & Johnson, ranked #46 with $21.1 million in total compensation

...a new FDA database that drastically improves timely access to information on drug safety labeling changes...part of the FDA's official website, was launched a few months ago by the FDA's Center for Drug Evaluation and Research...The agency now is leading a push to...get...critical safety data...much more quickly than in the past...The user-friendly and searchable database (www.accessdata.fda.gov) provides updates on labeling information, usually within days of safety labeling changes…Safety labeling changes have been available online...for years, but the information was posted on a monthly basis. That meant when a labeling change was approved early in a month, the information was not made public until the following month -- weeks later...

President Donald Trump says drug prices are astronomical and something needs to be done...Pharmaceutical giants have an answer that doesn’t involve lowering list prices: refunding some of the money to insurers if a drug doesn’t work as expected...The concept of pay-for-performance isn’t new in the industry. But the number of such agreements between drugmakers and insurers has grown in the past year as Big Pharma seeks to defuse criticism over the soaring prices of some brand drugs...In a sign of how central value-based programs have become in the pushback, the lobby group Pharmaceutical Research and Manufacturers of America plans to roll out the concept later this month to the media as part of proposals on addressing drug pricing concerns...While reimbursing part of the cost for a treatment that doesn’t perform well sounds like a sensible solution, the concept is hard to execute. In conditions like diabetes or high cholesterol, results can be tracked with simple numerical measures -- but it may be harder to pull off in areas like depression or cancer. There’s also little evidence that pay-for-performance will significantly lower drug prices overall...

The state of California has filed a civil suit against units of drugmakers Teva and Allergan, for allegedly obstructing generic competition to Lidoderm transdermal patches...The suit...alleges a "pay-for-delay" deal between the companies and Endo Pharmaceuticals, which already had its Lidoderm product on the market and had made $825 million off of it in 2011...Allergan signed an agreement with Endo Pharmaceuticals, promising that the company would not face any generic competition for Lidoderm from units of Allergan from May 2012 through September 2013 and in turn that Allergan would not face any competition from Endo until May 2014...anticompetitive agreements...lead consumers, payors and the State to pay, directly or indirectly, monopoly prices for Lidoderm medications and deny them the lower prices that generic competition provides...