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FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

The same drug company that donated $500,000 to a campaign to defeat marijuana legalization in its home state of Arizona in 2016 is now actively fighting to deter competition against its own synthetic THC product. Efforts to extend its exclusive right to manufacture the drug have resulted in a back-and-forth with a federal agency that ultimately resulted in the pharma firm’s request being summarily rejected.

Insys Therapeutics, a pharmaceutical company that came under fire over its anti-legalization election spending, is also known for producing potent opioids and a drug called Syndros, a synthesized THC product containing dronabinol that’s similar to Marinol, except that it’s a liquid preparation rather than a pill.

To many advocates, the company’s anti-legalization spending reeked of conflicts of interest. Was Insys worried that legal weed in Arizona represented a threat to its bottom line? The company essentially admitted as much in 2007, writing in a disclosure statement to the Securities and Exchange Commission (SEC) that “the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected” if marijuana or synthetic cannabinoids were legalized.

Now, according to publicly available documents, Insys is engaging in another type of battle. It wants extended exclusivity over its oral dronabinol product. And in October 2017, the company asked the Food and Drug Administration (FDA) to decline applications from competitors seeking to produce generic versions of Syndros.

Insys has already sued two such drug companies, Par Pharmaceuticals and Alkem Laboratories, after learning that they had submitted Abbreviated New Drug Applications (ANDA)—the first step in the process of gaining approval for generic versions of existing drugs—which “triggered a 30-month stay” in one case, Insys senior vice president of regulatory affairs Stephen Sherman noted in a October 2017 citizen petition to the FDA.

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In light of disclosures that drugmakers were submitting FDA applications to develop generic versions that referenced Syndros, which might eventually provide patients with cheaper alternatives, Insys appealed to the FDA.

Its request was in two-parts: 1) It asked the FDA to decline to “receive or approve” any ANDA applications that didn’t establish “in vivo bioequivalence” to its drug, and 2) that any ANDA applications for its drug “include fed and fasted state bioequivalence studies.”

In essence, Insys argued that its drug was too complex to be replicated by generic competitors that didn’t first conduct extensive testing demonstrating its biochemical likeness.

In a letter made public earlier this month, the FDA flatly denied the company’s petition. The government agency disputed the claims Insys included in its letter and clarified how the ANDA approval process works

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Robin Feldman, professor of law and director of the Institute for Innovation Law at UC Hastings College of the Law in San Francisco, literally wrote the book on all the different ways that mainstream pharmaceutical companies try to subvert generic competition.

She told Marijuana Moment that the bioequivalence testing Insys requested was already required in any ANDA application, so it was kind of like “petitioning the FDA to say ‘we insist that you do what it is that we all know you’re going to do.’ And with that, you get five months of delay.” In a phone interview, Feldman couldn’t help but laugh as she was read another section of the drug company’s citizen petition. That section says:

“Insys notes that it is currently awaiting an FDA exclusivity determination with respect to SYNDROS and expects to receive three years of exclusivity based on the submission of new clinical studies essential to approval.”

“Companies pile these exclusivities on one after another to keep generic competitors off the market as long as possible,” Feldman said. “So the reason I laughed is what you are seeing is a multipronged effort by the brand company to stave off generic entry as long as possible.”

“They’re using a variety of techniques: citizen petition, additional regulatory exclusivity, and adding these on. Each delay may be of limited time, but they may be extremely valuable—and together, they can add up to significant costs to the consumer,” she said.

In her book and published studies, Feldman reported that approximately 80 percent of citizen petitions, like the one submitted by Insys, were denied by the FDA. Submitting a citizen petition is often a delay tactic for drug companies hoping to maintain exclusivity over their brands, because “[d]elaying generic competition for as little as six months can be worth half a billion dollars in sales for a blockbuster drug,” she wrote in an op-ed for STAT.

False or misleading citizen petitions from drugmakers are so common, in fact, that Feldman created a beta “alert system” for users to submit and detect suspect petitions. When she ran Insys’s October 2017 petition through the system, it “came back with red flags,” she said.

Insys Therapeutics did not respond to requests for comment by the time of publication. This story will be updated if the company sends comment.

See the original article published on Marijuana Moment here:

FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

 

Warning: The Pharmaceuticalization of Cannabis has Begun

Warning: The Pharmaceuticalization of Cannabis has Begun

The opioid epidemic could be described through the life and tragic death of Sarah Fuller.

As a survivor of two car accidents who suffered from fibromyalgia, Fuller experienced debilitating pain that led to an opioid addiction. The drugs eventually caused kidney damage, but she managed to fight her dependency on opioids.

Fuller was clean when she entered the office of Dr. Vivienne Matalon in January 2015. She was still suffering from chronic pain and needed help managing her symptoms. Despite her history of opioid abuse, Dr. Malaton urged Fuller to “let the sales rep start talking about helping her with the pain,” according to Fuller’s father who witnessed the appointment.

The sales rep was from Insys Therapeutics, and the drug for sale was Subsys, a fentanyl equivalent dispensed as an oral spray and typically reserved for the terminally ill. The prescription drug is legal, and was delivered to Fuller’s door.

Fifteen months later, Fuller was dead. She was 32 years old. Her cause of death was recorded as “adverse effect of drugs.” Fuller’s bloodwork showed she had a lethal amount of the prescription drug in her system.

“As far as I’m concerned they killed her,”

said Fuller’s mother, who blames both Dr. Matalon and Insys Therapeutics. Matalon’s license has since been suspended.

The doctor, Insys Therapeutics and their sales reps, the legislation that allows a drug like this to be prescribed, and the politicians who help maintain the status quo can all share the blame for Fuller’s death, as well as their part in the opioid epidemic. Subsys is a Schedule II narcotic, which means the DEA believes it has some therapeutic benefits and is less dangerous than a plant – cannabis. Recently, the FDA awarded Insys with a Schedule II listing for their new pain medication Syndros, a synthetic form of THC, even though marijuana itself is still a Schedule I substance.

Meanwhile, Insys has been actively lobbying to stop marijuana legalization efforts, and is listed among the most dangerous companies fighting legalization to maintain revenue.

Why do pharmaceutical companies care if cannabis is legal?

The reality is pharmaceutical companies see the benefits of cannabis as a non-addictive painkiller that’s inherently safer than opioids. By spending millions of dollars on lobbying to keep marijuana illegal, they can market their own cannabis medication and sell it legally.

The process is made easier by having former DEA officials take jobs at pharmaceutical companies. An investigation by The Washington Post showed that 42 former DEA employees have taken jobs at pharmaceutical companies since 2005, 31 of which have a background in regulation.

“There’s this misconception that illicit markets are run by dangerous criminals, while prescription markets are run by responsible business people, when the truth is that these are not mutually exclusive classifications,”

said Amanda Reiman, former manager of marijuana law and policy at the Drug Policy Alliance.

“Insys has made their money off peddling an extremely dangerous drug, so the idea that they somehow now have this benevolent motivation to provide cannabinoid medication to the public is just a horse and pony show meant to usher in the pharmaceuticalization of cannabis.”

Dr. Lester Grinspoon’s warning

Dr. Lester Grinspoon, a longtime medical marijuana advocate, anticipated the pharmaceutical industry’s attempt to take ownership of cannabis-based medicines.

“The ‘pharmaceuticalization’ of marijuana will only succeed if pharmaceutical products displace marijuana as a medicine,” Grinspoon wrote in 2001. While he seemed to think this was improbable, “due to the plant’s limited toxicity, easy availability, low cost relative to pharmaceuticals, ease with which it can be self-titrated, and remarkable medical versatility,” Syndros is an example of Grinspoon’s “pharmaceuticalization” coming to fruition.

While the Fuller family seeks justice for their daughter, the opioid epidemic continues with some help from the Trump Administration. Tom Marino is suspected to be Trump’s choice for the Drug Czar position. He was a proponent of the Ensuring Patient Access and Effective Drug Enforcement Act, a bill that opponents said would make it more difficult for the DEA to prosecute pharmaceutical companies. He will also have an ally in Attorney General Jeff Sessions, who has vocally opposed medical marijuana as a legitimate medicine. Trump also wants Dr. Scott Gottlieb to run the FDA, who has been paid by opioid manufacturers to speak at events.

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