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.

A TIMELINE

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.

PAYMENTS OF OFFICE STAFF SALARIES AND AGREEMENTS FOR NON-EXISTING SPEAKING ENGAGEMENTS

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.

THE KICK-BACK SCHEME LED TO SKYROCKETING PROFITS

“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.

LOBBYING AGAINST CANNABIS LEGISLATION IN ARIZONA TO WARD OFF COMPETITION WITH ITS OPIOID, AS IT DROPPED ITS CANNABIS PRODUCT

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.

SOCIAL GATHERINGS WITH FORGED SIGN-IN SHEETS, UNDISCLOSED ALCOHOLIC DRINKS AND MEALS FOR DOCTORS, NURSES AND PHYSICIANS’ ASSISTANTS AND A WHISTLEBLOWER LEAD TO FALSE CLAIM ACT CHARGES

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.

NEW MANAGEMENT INITIATIVES

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.

In Bipartisan Effort, Federal Government Moves To Combat The Opioid Crisis

As the opioid epidemic rages on with a record 72,000 overdose deaths in 2017, President Trump recently signed into law SUPPORT for Patients and Communities Act – an opioid-related legislation package which passed in Congress by a wide bipartisan margin. This package takes a step toward combatting the opioid epidemic by increasing grant monies, expanding access to prevention programs and treatment services, and working to prevent interstate mail-based trafficking of fentanyl.

Although the opioid crisis represents the most critical public health crisis since the 1918 Spanish flu pandemic—with the number of opioid-related overdose deaths increasing by record-breaking numbers every year—there has been no appreciable effort by the pharmaceutical industry to mitigate the risks associated with the misuse of highly-addictive products.

The passage of this bill with broad bipartisan support indicates that the federal government will move forward with efforts to tackle the crisis – even without substantial input or action from pharmaceutical industry.

Thanks to Brexit – EMA Leaves London for Amsterdam

In anticipation of its move from London, the European Medicines Agency (EMA) has been working closely with Dutch authorities to help smooth its relocation to the Netherlands. The move is expected to occur by March 30, 2019.

EMA, which facilitates the development and access to medicines in the EU, has been located in London since it was established in 1995. Despite voting to withdraw from the EU in 2016, the UK had expressed hope that EMA would remain in its longtime location on Canary Wharf. But on November 20, 2017, EU Member States voted that in the wake of Brexit, EMA would not remain in Britain but would be relocated to an EU member country. Amsterdam won the competition to house the EMA and the agency has since signed a Seat Agreement with the Dutch government which will permit the EMA to function independently in its new location.

In order to best prepare for the consequences of Brexit, the move to Amsterdam, and subsequent loss of staff, the agency has initiated a temporary suspension or scaling back of various activities so that its core activities of evaluation and supervising medicines can proceed with as little disruption as possible.

Among other activities, guideline development and revision has been scaled back in order to prioritize the guidelines which address urgent public/animal health needs or are necessary to prepare for Brexit. More detailed information can be found in EMA’s Brexit Preparedness Business Continuity Plan. More reductions are expected in advance of the actual re-location to Amsterdam.

EMA has also released information for pharmaceutical companies concerning cut-off dates for appointments of (co)-rapporteurs from the UK.

Additionally, EMA has created a Tracking Tool which displays various logistics and milestones related to its relocation from London.

We at Contracts Associates are also monitoring the impact that Brexit will have on the treatment of EU citizens’ transfers of personal data to sponsor data server’s located in the UK, which will be outside of the EEA, post-Brexit. We’ll cover this in future blogposts.

 

When Sponsors Need a Lifeline, Rescue Contract Reviews Can Get a Clinical Trial Back on Track

Delays can be the death of a clinical trial. Late starts and missed milestones can deteriorate sponsor-site relations and waste both parties’ time, resources, and patience. And when studies get off to a shaky start, it’s all too easy to rush other obligations in a desperate bid to make up time—jeopardizing the study’s success.

Due to a lack of in-house resources or legal expertise, many sponsors find themselves unprepared to strategically negotiate these agreements within the available time frame before a trial’s projected start date. This makes it even more difficult to secure mutually beneficial terms and maintain a positive working relationship with the site.

When it looks like a study is hitting a standstill, agile legal vendors like Contracts Associates can swoop in to save the day. “Sometimes after entering into an agreement with a CRO, a sponsor finds that they’ve under-resourced. They don’t have the legal support they need. That’s where we step in,” says Contracts Associates President and Founder, Colleen Sproul. “We’ve performed fast and reliable “rescue contracts reviews” for countless sponsors over the years, helping to support our clients in meeting their milestones.”

Here are some areas where sponsors commonly run into trouble, and where a rescue reviewer can help get you out of the weeds and on track to meet your milestones.

Approaching contract reviews without experienced negotiators on your team

Negotiating contract terms is always a balancing act. You have a budget and timelines to consider, and intellectual property and a reputation to protect. And if your site is a major research institution, it’s more than likely that their vast and experienced legal team is combing over every clause with an eagle eye.

Unfortunately, some sponsors lack the in-house legal knowledge to negotiate equitable contract terms and handle reviews with the necessary efficiency. And without a thorough and strategic approach to contract reviews, all manner of unfavorable terms can slip through the cracks. You may find yourself taking on unnecessary responsibilities and shouldering a troubling level of risk. And if you don’t pay close attention to the agreement, the investigator may be entitled to publish data long before you’re ready to see it go public.

The idea that any agreement is better than no agreement is a damaging one. If you find your company struggling to finalize a favorable clinical trial agreement with target deadlines looming, take a step back before signing and harness experienced outside help.

An outsourced legal vendor with experience in rescuing contract reviews can enter the review process to expedite negotiations, smooth out seemingly inflexible terms, and help find a mutually-beneficial middle ground—so you don’t have to settle for the simplest compromise.

Rushing into an agreement because the in-house legal team is overwhelmed

Even sponsors with in-house legal teams can run into these delays. In the buildup to a clinical trial, the rush to meet milestones can quickly cause in-house counsel to get stretched too thin—leading to a backlog of contracts waiting for review. This opens the door to mistakes and missed opportunities, slowing the process down significantly.

The time and expense it takes to hire and onboard another full-time attorney would only exacerbate the delay. This can leave sponsors stuck between a rock and a hard place, unable to expand their team but incapable of meeting their milestones with the resources they have.

Outsourced legal solutions can solve this problem, offering rescue contract reviews on an as-needed basis. Your in-house counsel is supported by an entire team of lawyers who share their industry knowledge and don’t require explanations before getting to work. This allows you to ensure that every term is meticulously crafted and any loopholes effectively tied up—before you make them legally binding.

Rescuing contract reviews, supporting sponsors at every step

At Contracts Associates, our firm was founded to steer sponsors toward success—and our rescue contract review services have helped many of our clients get there against the odds.

All our lawyers match deep contract review knowledge with extensive in-house experience and established relationships with prominent research institutions. This allows us to enter the contract review process at any stage without wasting time getting up to speed or aggravating strained relationships between sponsors and sites.

And since our attorneys work remotely, we’re able to work flexibly and work fast—so you can meet your milestones and avoid endless (and costly) delays.

Of course, no sponsor sets out thinking they’ll need rescue services. Prepare for any eventuality and ensure your success by having a solid contract review plan in place from the very beginning. We can help. From crafting meticulous contracts to creating a customized library of agreements for your company, we can support you from the outset—so you can enter the clinical trial phase with confidence.

Ready to expedite your contract review process? Contact us today.

UPDATED August 13, 2018: Bill Limiting Non-Compete Agreements Is Now Massachusetts Law

UPDATED on August 13, 2018:

Non-Compete reform has become Massachusetts law.

On Friday, August 10, 2018 Governor Charlie Baker signed “An Act relative to the judicial enforcement of noncompetition agreements” regulating the use of non-competition agreements and limiting the ability of employers to enter into and enforce non-compete agreements with Massachusetts employees. This new law is scheduled to take effect on October 1, 2018 and promises a changing landscape for Massachusetts businesses.

We look forward to helping our clients respond to the new regulations. Please contact our office with any questions concerning the enforcement of any currently-existing consulting agreements or ensuring the compliance of future agreements.

Originally Published on August 1, 2018:

Massachusetts Legislature Passes Non-Compete Reform – Next Stop is Governor’s Desk

In negotiations extending into the late-night hours, Massachusetts lawmakers passed a bill reforming non-competition agreements just before the midnight deadline. The bill, entitled “An Act relative to the judicial enforcement of noncompetition agreements”, has been sent to Governor Baker’s desk for signing. If signed within the next ten days, the act regulating the use and enforcement of non-competes will take effect in October 2018. We will be watching the State House closely over the next few days and will announce the signing of the bill when and if it occurs.

Originally Published on July 27, 2018: An economic development bill restricting the use of non-compete agreements has passed both the Massachusetts Senate and House. The bill, which limits the restrictions that employers may place on workers leaving to join competitors, has gone to conference committee where it must be hammered into final form. Legislators in both chambers must vote on the bill before the close of the legislative session at midnight on July 31, 2018.

Contracts Associates will monitor new developments related to this bill. If the legislation is enacted, we’re prepared to advise on the effect the changes will have on the enforcement of consulting agreements currently in place, as well as suggest any necessary changes to contract templates.

Contracts Associates Will Attend FDA Boot Camp in September 2018!

We are pleased to announce that Contracts Associates will attend ACI’s FDA Boot Camp in Boston this September! At this conference, we’ll join hundreds of other members of the Life Sciences community over a two-day span as we enhance our expertise in FDA regulatory law. With workshops covering everything from the clinical trial process for pharmaceutical products, to application and approval, ethical challenges, and more, this promises to be an informative and engaging experience!

Before Rushing to Build an In-House Legal Team, Read This Advice On Effective Outsourcing

Valuable time wasted explaining basic life sciences concepts. Substandard work that needs redoing. Poor communications and poorer results—leading to endless clinical trial delays and contracts of dubious validity.

The damage caused by outsourcing legal work to a low-quality, inexperienced vendor can be enough to make sponsors shy away from this practice for good. As a result, many sponsors are considering a return to traditional ways of working—hiring in-house legal counsel. But is this move viable in the long-term? Or will the shift remind sponsors why they turned to outsourcing in the first place?

One advocate for high quality outsourced legal work is Colleen Sproul, the President and CEO of Contracts Associates, Inc. Her company’s mission is to deliver the expertise and experience of in-house counsel combined with the agility and responsiveness of an outsourced vendor. She founded the company in 2006 in response to a significant gap in the clinical trial process that she knew she could fill.

“Sponsors were typically taking on recent law school grads or temps from staffing agencies to review their clinical trial contracts,” Colleen says. “I saw an opportunity to draw on my own prior in-house experience to provide sponsors with expert, expedited contract review on an as-needed basis so that their clinical trials could get up and running on time and with the proper protections in place.”

Colleen’s team comes in with the on-point biotech and pharmaceutical experience required to hit the ground running. In fact, extensive life sciences experience is a prerequisite for joining her team of attorneys. In contrast, temp attorneys and fresh-faced law grads frequently struggled to grasp the ins-and-outs of the clinical trial process—opening the door to inefficiencies, careless mistakes, work needing to be redone, and long, laborious explanations.

So why had sponsors started outsourcing in the first place? At the time, many assumed it would allow them to sidestep the higher long-term costs associated with hiring an in-house team.

“Hiring a new employee is a serious investment,” explains Colleen. “The recruiting and onboarding process is time-consuming and involves substantial resources. Training is intensive. The compensation package for top talent is often significant. Especially for short-term studies, it makes no sense to go through all this effort only to lay off the employee in a year when the study is over.”

This was the problem Colleen set out to solve by forming Contracts Associates. As an attorney with vast biopharma experience, she sought to offer a cost-effective solution that delivered all the benefits of an in-house legal team without any of the drawbacks.

In-house counsel, for example, will frequently find themselves bogged down by other responsibilities and competing deadlines, leading to delays. But an outsourced vendor can dedicate all their time and energy to expediting the contract review process and clearing backlogs.

Colleen took this one step further. From the very beginning, she chose to keep her company virtual, giving her team the freedom to work flexible hours dependent on their clients’ needs.

“By having my team work remotely, I’m able to recruit top talent no matter where they are geographically located,” she says. “We aren’t constrained by a typical workday. We routinely communicate with clients and clinical sites all over the world, and we can meet deadlines for clients in the EU or Asia as easily as we do in Boston.”

Since outsourced solutions were designed specifically to help sponsors avoid the unnecessary expense and difficulty of building an in-house team, Colleen views the recent trend toward in-sourcing staff as a step in the wrong direction—and one which could be costly. Rigid and outdated, this approach can never offer the same versatility and responsiveness that outsourced teams like Colleen’s can deliver.

So how can sponsors be sure they’re working with a vendor that will deliver the exacting standards they require? Colleen has some advice.

“I’d recommend looking for an established company with demonstrable experience and expertise in the life sciences,” she says. “Look for depth and breadth of in-house experience among the team. A company should be responsive and demonstrate clarity and confidence in their turnaround times.”

Ultimately, outsourced solutions can offer the same expertise as in-house counsel with the added agility sponsors need to meet their milestones and get their clinical trials off the ground. Since these solutions are available on an as-needed basis, they avoid the restrictiveness of long-term hiring. By taking the time to research a vendor first, sponsors can avoid facing problems down the line.

“Our company is dedicated to handling contract reviews—it’s what we do,” Colleen says. “We’re like hired guns for the pharmaceutical and biotech industry!”

To learn more about Contracts Associates or for advice about expediting your contract review process, get in touch today.

How EU GDPR Affects Collection of Biometric and Genetic Data

As we look toward the new European Union General Data Protection Regulation (GDPR) which takes effect this week, we expect some of its provisions to affect U.S-based life sciences companies conducting clinical trials at EU sites, particularly related to the collection of genetic and biometric data.

GDPR governs how data controllers and processors are permitted to engage with the personal data of EU citizens.  The new legislation differs from the former controlling legislation, the Data Protection Act, in some key ways. GDPR is broader in scope than the previous directive meaning that, as of May 25, 2018, even non-EU based companies will be subject to more extensive regulation.

GDPR implements a new extra-territorial rule, so that no matter if a company is based in the EU or not, it is still bound by GDPR if certain criteria are met. For example, even if a data controller (i.e., a sponsor) or processor is not established in EU, they will be bound by GDPR if they’re processing the data of individuals within the EU. Sponsors in the U.S. may now find themselves obligated by the GDPR privacy protections where they were not bound before. Member States are also free to impose further restrictions on the processing of health-related data.

The life sciences industry and clinical studies are clearly reliant upon the data that are collected from participants within clinical trials. GDPR introduces new, explicit privacy protections for such health-related data.

GDPR specifically categorizes genetic and biometric data—which is the type of health data upon which clinical trials largely rely—as “sensitive personal data”. Under GDPR, the processing of genetic or biometric data is prohibited unless an exception applies. In the clinical trials context, an exception that might commonly apply is gaining the consent of the data subject.

In an effort to protect the interests of individuals where an imbalance of power could occur or the possibility of serious data protection risks exist, GDPR has heightened the standard of consent to mean “any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she, by a statement or clear affirmative action, signifies agreement to the processing of personal data related to him or her.”

This definition will provide the framework for sponsors gaining the necessary explicit consent from individuals who are considering joining a clinical study, such as via a written statement or informed consent contract.

As we approach May 25, 2018, sponsors must ensure that all informed consent contracts are compliant with GDPR and meet explicit consent standards as well as all other contractual obligations so that all prospective participants are protected and the sponsor is in compliance.

Contracts Associates has been working to help our clients navigate this new regulatory framework. Our team of attorneys has the deep experience and expertise necessary ensure that all of your informed consent agreements meet the higher bar that GDPR has introduced. We help our clients minimize the risk of penalties by updating contracts and providing reviews to ensure that all informed consent language is GDPR-compliant. If you haven’t yet contemplated how GDPR might change affect your study, please contact our CEO, Colleen Sproul, at cms@contractsassociates.com or call 781-598-8000 so that we can help guide you.

UPDATED MAY 31, 2018: House Passes “Right to Try” bill – Compromising Public Health and Drug Development

UPDATED MAY 31, 2018

On May 30, President Trump has signed the “Right to Try” bill into law which allows terminally ill patients to bypass the FDA when attempting to gain access to experimental therapies. Patients have already been able to apply for investigational drugs outside of clinical trials via the federal “Expanded Access” law.

The Right to Try legislation does not guarantee that manufacturers will provide the drugs nor that insurance companies will cover the costs. The law was backed by libertarian think tank the Goldwater Institute.

Originally published on April 18: On March 21, only one week after an initial defeat in the U.S. House, the controversial “Right to Try” bill was passed by a vote of 267-149. The legislation is now on its way to the U.S. Senate.

“Right to Try” would provide access to experimental therapies to patients with life-threatening illnesses while weakening FDA oversight and compromising public health and medical research. The FDA already offers patients access to experimental drugs or medical devices outside of clinical trials via the Expanded Access (sometimes called Compassionate Care) program and approves the overwhelming majority of all applications received—about 99%. Under Expanded Access, the FDA continues to supervise administration of the experimental drugs which both helps reduce individual patient risk and works to improve overall public health outcomes.

The current “Right to Try” bill permits patients and their doctors to bypass the FDA and work directly with pharmaceutical companies for access to drugs which have merely completed Phase I clinical trials. Some patient groups argue that by cutting out FDA oversight and creating an alternative avenue for accessing experimental drugs, Right to Try actually increases patient risks and is demonstrably less safe than Expanded Access.

Over 75 patient groups sent a letter to the House opposing passage of the bill, citing the dangers it presented to patients such as the seven-day lagtime between patient access to the investigational therapies and FDA notification of any possible side effects or negative outcomes. Additionally, the patient groups cited the removal of FDA-sanctioned dosing and safety measures. They also cited shortcomings of the bill such as its failure to address significant barriers to patients such as access and cost.

The bill strips patients of potential legal remedies by protecting doctors and drug companies from liability in the case of negative outcomes for patients.

The legislation is also poised to compromise medical research and drug development by preventing the FDA from using any data from negative clinical outcomes in its drug-approval assessments. Barring FDA from using such data would shroud the successes or failures of the experimental drugs in obscurity—possibly preventing further large-scale advances in overall research and development.

Ultimately, “Right to Try” strips the FDA of established regulatory authority and protections, increases risk to patients, and obfuscates data and outcomes vital to continued success in research and development–all of which could result in serious, wide-ranging public health issues.

We at Contracts Associates will continue to monitor this important issue.