Tag Archives: big pharma

FDA Wants To Stop Pharma From ‘Gaming’ Generic Drug System

The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition.

“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he said in the blog post. “We are actively looking at ways our rules are being used and, in some cases, misused.”

The move comes as President Donald Trump and lawmakers in Congress search for ways to lower the cost of prescription drugs. Trump is preparing to put out an executive order on drug pricing, according to media reports, and last week U.S. Senator Ron Wyden introduced a bill to require companies to explain the reasons for significant price increases.

Full Read – http://www.nbcnews.com/health/health-news/fda-wants-stop-pharma-gaming-generic-drug-system-n775151

6 pharma executives face criminal charges for alleged fentanyl racketeering scheme

Six pharmaceutical executives who worked for Chandler, Ariz.-based Insys Therapeutics were arrested Thursday on charges that they led a nationwide conspiracy to bribe clinicians to unnecessarily prescribe fentanyl-based pain medication, according to the Department of Justice.

The government claims the executives conspired to bribe physicians and medical practitioners in several states, many of whom worked in pain clinics, to prescribe their pain medication called Subsys. This narcotic contains fentanyl, a highly addictive synthetic opioid, and is intended to treat cancer patients suffering intense episodes of breakthrough pain.

In exchange for kickbacks and bribes, practitioners allegedly wrote large numbers of prescriptions for patients, few of whom were diagnosed with cancer. The indictment also alleges the former Insys executives conspired to defraud health insurers that showed reluctance to approve payment for Subsys when it was prescribed to non-cancer patients. The defendants allegedly did so by establishing a “reimbursement unit” that obtained prior authorization directly from insurers and pharmacy benefit managers.

Here are the names of the defendants, all of whom are no longer employed by Insys Therapeutics, along with the respective charges they face:

  • Michael Babich, former president and CEO: conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law
  • Alec Burlakoff, former vice president of sales: Racketeer Influence and Corrupt Organizations Act conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Richard M. Simon, former national director of sales: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Sunrise Lee, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Joseph A. Rowan, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Michael J. Gurry, former vice president of managed markets: RICO conspiracy and wire fraud conspiracy

Criminal charges are rarely pressed in cases involving pharmaceutical companies, and several agents noted the severity of the charges in statements.

Full Read – http://www.beckershospitalreview.com/legal-regulatory-issues/6-pharma-executives-face-criminal-charges-for-alleged-fentanyl-racketeering-scheme.html

Sanofi Files Suit Against Merck, Claiming Patent Infringements

French drugs firm takes legal steps to prevent the launch of rival versions of its diabetes treatment

A packet of diabetes drug Lantus SoloStar on the production line at a manufacturing site of French drugmaker Sanofi in Frankfurt, Germany. The French company has filed a lawsuit against U.S. peer Merck & Co. to prevent it from launching a rival version of its diabetes treatment. PHOTO: REUTERS

PARIS— Sanofi SA said it filed a lawsuit against Merck & Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant’s best-selling diabetes treatment Lantus.

In the filing in the U.S. District Court of Delaware, Sanofi said on Monday it claims that Merck Sharp & Dohme Corp., Merck & Co.’s international division, violated as many as 10 patents held by the French company, including ones for its insulin Lantus and its insulin delivery device soloSTAR.

The Paris-based drugs company said it started the legal proceedings against Merck after the U.S. firm’s filing for new drugs applications with the U.S. Food & Drug Administration.

A spokeswoman for Merck said the company’s product “doesn’t infringe Sanofi’s patents.”

Sanofi shares were 1.3% higher at €69.91 in midday trading.

The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue.

In the first six months of the year, diabetes revenue fell by 6% to €2.9 billion ($3.2 billion), hit by a 15% drop in Lantus sales to €2.38 billion. The company has said it expects revenue from diabetes drugs to continue to decline this as competition among insulin makers intensifies.

In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi.

In a bid to replenish its new drugs pipeline and revive growth, Sanofifor months had pursued U.S. biotech Medivation—a Nasdaq-listed company that focuses on hard-to-treat cancers, markets one prostate-cancer therapy, Xtandi, and has two other oncology assets in clinical development.

But U.S. pharma giant Pfizer Inc. beat out Sanofi grabbing Medivation for $14 billion in August.

Sourced From  – http://www.wsj.com/articles/sanofi-files-suit-against-merck-on-patent-infringements-1474285467

Big Pharma Promotes Legal Drug Addiction

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Big Pharma Promotes Legal Drug Addiction

Many of us believe that Big Pharma must be held accountable for this dangerous opioid trend, especially since several have been caught lying about the benefits and risks of their drugs.

As noted by the Organic Consumers Association (OCA), the drug industry has “fostered the opioid addiction epidemic” in several ways, by:

  1. Introducing long-acting opioid painkillers like OxyContin, which prior to reformulation in 2010 could be snorted or shot. Many addicts claimed the high from OxyContin was better than heroin. In fact, from a chemical standpoint, OxyContin is nearly identical to heroin, and has been identified as a major gateway drug to heroin.
  2. Changing pain prescription guidelines to make opioids the first choice for lower back and other pain conditions that previously did not qualify for these types of drugs. Even the World Health Organization (WHO) has had a hand in this problem, although it restricted its promotion of narcotic painkillers to cancer patients.
  3. Promoting long-term use of opioids, even though there’s no evidence that using these drugs long term is safe and effective
  4. Downplaying and misinforming doctors and patients about the addictive nature of opioid drugs. OxyContin, for example, became a blockbuster drug mainly through misleading claims, which Purdue Pharma knew were false from the start. The basic promise was that it provided pain relief for a full 12 hours, twice as long as generic drugs, giving patients “smooth and sustained pain control all day and all night.”However, for many the effects do not last anywhere near 12 hours, and once the drug wears off, painful withdrawal symptoms set in, including body aches, nausea and anxiety. These symptoms, in addition to the return of the original pain, quickly begin to feed the cycle of addiction.7

A 2015 article in The Week does a great job revealing the promotional strategy developed by Purdue, and backed by the US Food and Drug Administration (FDA), that has led to such enormous personal tragedy.

As noted in this article: “The time-release conceit even worked on the FDA, which stated that ‘Delayed absorption, as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.’”

Other recent research has found that medical marijuana lowers prescription drug use.

The Big Q: Could that be why it hasn’t been rescheduled?

There are no other truly compelling reasons why addictive narcotics like OxyContin are legal, while marijuana, which is extremely unlikely to kill even if one take very high amounts is not.

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Read Full Article – http://www.livetradingnews.com/big-pharma-promotes-legal-drug-addiction-10406.html#.V6F8KZMrKRs