No Successor Yet Named For Head of UK Medicines Agency

As the deadline date for the UK withdrawal from the EU rapidly approaches, no successor has yet been named to take the place of the head of the UK Medicines and Healthcare Regulatory Agency (MHRA).

Late last fall, Dr. Ian Hudson announced that he will resign his position as CEO of the MHRA. Dr. Hudson has served as CEO of the watchdog agency since 2013 with much of his current role including serving as the UK delegate to the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency (EMA). Indeed, Dr. Hudson has been the Vice-Chairman of CHMP since October 2012.

Dr. Hudson does not appear to be leaving for a particular employment alternative, rather, he stated, “I feel the time is right for a new person to guide the agency and our work through its next phase, following the UK’s departure from the European Union next year.” The resignation will take effect in September 2019, about six months after the UK leaves the EU.

With only two months to go before the March 29, 2019 Brexit date, there remains no deal in sight. According to its long-term Brexit plan, MHRA is moving forward with preparing for the possibility of a hard Brexit.

MHRA Post-Brexit

If the UK exits the EU without a deal which includes provisions for a relationship with the European Medicines Agency, the MHRA will lose access to all EU regulatory networks and will serve as a standalone drug regulator – handling all responsibilities that are currently overseen by the EMA, such as drug approvals, general oversight of medicines, and clinical trials. The MHRA has released some proposed arrangements for regulation in the case of a no-deal scenario.

The resignation of Dr. Hudson and the search for a successor to guide the agency adds a yet another layer of uncertainty as to the future of the MHRA in the aftermath of Brexit.

As the March 2019 UK withdrawal date approaches, we at Contracts Associates will continue to provide updates on our blog in relation to the impact of Brexit on existing appointments of UK entities as EU legal representatives as well as recommended revisions to UK informed consents, once the UK is no longer subject to the EU GDPR.

Insys Therapeutics: Everything The Pharmaceutical Industry Is Doing Wrong In Response To The Opioid Crisis

Prescriptions in exchange for cash, alcohol-fueled social gatherings with prescribers, and wrongful deaths all allegedly played a part in the downfall of Insys Therapeutics, Inc.


As Insys Therapeutics, Inc.’s former top executives plead guilty to federal criminal charges, Insys’ new management will pitch the company’s pivot from opioid-related assets to cannabinoids to the attendees of the J.P. Morgan Chase Healthcare Conference on January 10, 2019.


The story of this dramatic shift in a formerly-successful company’s business model is being spun by some as a cautionary tale for an industry that is under government scrutiny as prescription opioids continue to feed the opioid crisis here in the US. The downfall of the company turned on consulting contracts with, and payments to, potential subscribers for services never actually rendered.


“Subsys”, a powerful, highly-addictive fentanyl spray, was approved for cancer patients suffering from episodes of severe pain. Sales of Subsys were initially flat following its 2012 launch, despite its efficacy, until Insys executives allegedly developed a kick-back scheme to vastly increase sales – by bribing targeted medical practitioners. The former Insys executives are accused of paying doctors to increase both the number and dosage of the Subsys prescriptions they wrote – even if the patients were not suffering from cancer and didn’t actually need the drug. The doctors who prescribed the most Subsys allegedly received bribes and kickbacks in the form of checks in payment of speaking gigs that never happened, or by Insys’s payment of the salaries of the doctors’ office staff.

As the opioid epidemic and related deaths surged to unprecedented numbers, Insys’s stock skyrocketed. The new darling of investors, Insys posted major gains in the stock market and became the top IPO of 2013. Investors and shareholders were enriched and the wealth of its founder, John Kapoor (now also facing federal charges), was boosted to billionaire status. Insys generated $329.5 million in net revenue in 2015; Subsys was its only marketed non-generic drug. In 2016, the company sold $240 million worth of Subsys.


Prior to the 2016 General Election in Arizona, Insys donated $500,000 to a group that opposed the legalization of cannabis for recreational use in Arizona: Arizonans for Responsible Drug Policy. The Insys donation was about five times the second largest donation ($110,000) received by the lobbying group. The contribution raised eyebrows at the time, and U.S. News and World Report spoke for a concerned public when it opined, in a September 8, 2016 article that:

“It’s hard to imagine a more sinister donor than Insys Therapeutics Inc. in the eyes of pot legalization proponents, who long have claimed drug companies want to keep cannabis illegal to corner the market for drugs, some addictive and dangerous, that relieve pain and other symptoms.”

Interestingly, from 2011 to 2015, Insys sold one other controversial product: a generic equivalent to what is now AbbVie’s Marinol®, a synthetic version of the cannabinoid THC (tetrahydrocannabinol). Marinol® is approved by the Food and Drug Administration for treatment of cancer and HIV-related symptoms like nausea and loss of appetite, but is controversial because cannabis advocates say the raw plant material is as effective as the marketed product. During this timeframe, the Obama administration, in response to, among other things, a 2014 Johns Hopkins University study that tied medical marijuana laws to much lower state-level opioid overdose mortality rates, was encouraging states to pass their own decriminalization laws as marijuana is an remains as Schedule I substance.


According to ProPublica, “The company’s highest volume prescriber was Dr. Paul Madison, who prescribed 58 percent of Subsys prescriptions in the state despite treating “few, if any, cancer patients.” Madison was indicted in December 2012 on federal false claims charges for billing insurers for non-existent procedures.” Insys CEO went on to allegedly conspire with Dr. Madison to “getting patients started on Subsys in Indiana” and “Insys paid Madison more than $87,000 for speaking, travel and food from 2013 through 2015”.

The alleged bribery scheme did not fall apart, however, until a whistleblower who was fired after she stopped showing up to work due to guilt over her role in getting insurance companies, on behalf of doctors and patients, to get Subsys reimbursed by the companies, stepped forward and investigations into Insys’s top executives were launched. In June 2015, a Connecticut nurse pleaded guilty to receiving kickbacks in connection to speaking payments she received from Insys while she was the top prescriber of Subsys to Medicaid patients in Connecticut. In February 2016, a sales representative in Alabama pleaded guilty to fraud charges; in June 2016, months before its August donation to the Arizona anti-cannibis lobby, two Insys sales representatives were charged in New York with violation of the Federal Anti-Kickback statute; and in September 2016, a third employee was charged: all in relation to kickbacks to doctors involved in speaking programs.

As legal troubles mounted, Insys shares and sales plummeted. The company, currently facing additional lawsuits and investigations, (including a lawsuit filed by the Illinois’ attorney general, accusing Insys of deceptively marketing and selling Subsys to doctors for off-label uses) continues to hemorrhage money as it fields the costs of the legal defenses of its former executives. The top prescriber of Subsys in Kansas is facing three wrongful death lawsuits and it turns out that the Insys sales rep who worked with him is actually a whistleblower working with the FBI.

Insys has also agreed to pay $150 million dollar to the Department of Justice to settle an investigation into its kickback schemes. As a result of the scheme in the last five years, federal healthcare programs incurred millions of dollars in losses.


As new Insys management looks to distance itself from the opioid epidemic, it is scrambling to find a buyer for all its opioid-related assets, including Subsys. Riding the wave of marijuana-legalization laws that are now sweeping the country, Insys plans to return to pharmaceutical-grade cannabinoids. Strong, clear contracts and structured speaker programs will no doubt be priority number one for the new management as it conducts upcoming clinical trials.

Meanwhile, as we move into the new year, the opioid epidemic continues to rage on with little sign of abating and no meaningful oversight or action from the pharmaceutical industry to combat the epidemic seems imminent.