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.

Sidestep FDA Form 483—And The Resulting Setbacks

Bringing a new drug or medical device to market is incredibly exciting for any sponsor. Ideally, you’d like the clinical trial phase to proceed without delays, so you can get your new drug to market quickly—and start helping patients.

The FDA can issue a Form 483 after an inspection where an investigator has observed conditions or issues at a facility that might constitute violations of the Food Drug and Cosmetic Act and serves to alert the organization’s management. As a best practice, if issued a 483, companies or research centers should respond in writing without delay. The response should include a corrective action plan addressing the violations which the organization should immediately implement. Failure to respond or failing to take remedial measures could result a Warning Letter being issued by the FDA, or cause delays in studies and development.

The FDA maintains a list of Inspectional Observation Summaries broken down by program area (biologics, bioresearch monitoring, drugs, devices, etc.) which can be found on the FDA website. By viewing this data, sponsors, clinical sites, CROs and IRBs have the opportunity to learn the most common reasons for 483 and how to avoid similar pitfalls during the clinical trial process.

For example, in the program area of Bioresearch Monitoring, 248 Form 483s were issued between 10/1/2016 and 9/30/2017. Common reasons for the 483 include:

• An investigation was not conducted in accordance with the signed statement of investigator and/or investigational plan (frequency: 140 times)
• Failure to prepare or maintain adequate and/or accurate case histories with respect to observations and data pertinent to the investigation and/or informed consent (76 times)
• Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB and/or was not signed by the subject or the subject’s legally authorized representative at the time of consent and/or was not dated by the subject or the subject’s legally authorized representative at the time of consent. (14 times)

Stick to the plan

An investigational plan forms a roadmap for any clinical trial, giving a brief overview of the type and scale of the study. Mandated by the FDA, it’s the outline that gets a trial from start to finish: quickly and safely. Sponsors and investigators must either stick to this plan, properly amend it—or risk receiving a Form 483.

An investigational plan is detailed and thorough, but a sponsor won’t typically be on site to ensure it’s being followed. As such, it’s important to know that your contracts and terms with your CROs are solid and equitable. Failing to review contracts could leave you open to both liability and FDA delays. Our attorneys possess the necessary industry experience and a meticulous, efficient approach to contract reviews which means sponsors can be confident that they’re protected should an investigational plan go awry.

Let the record show everything

To gain the best results from a trial and to pass inspections, meticulous record keeping is a must. Much like an investigational plan, proper record keeping requires diligence and thoroughness. It involves preparing and maintaining case histories and taking detailed documentation at every stage, from observation to delivery. Failing to properly monitor and maintain records for a trial isn’t just a common reason for a Form 483, but can also compromise the study.

Contracts Associates will ensure that each sponsor/CRO agreement includes detailed language about monitoring and record keeping. The agreement is intended to protect the sponsor in the event your CRO fails to keep proper records. Working with us will allow sponsors to harness our knowledge and expertise, which means you won’t have to worry about this type of exposure.

Obtain informed consent

The FDA doesn’t just monitor the safety of publicly available drugs or devices. It also monitors the safety of clinical trial participants, and obtaining informed consent is a core element of that.

Sponsors must ensure trial participants know their rights in relation to a clinical trial they’re considering. This includes exposure to unknown risks, possible side effects, and potential outcomes. Ensuring that your study is compliant with FDA regulations about informed consent is crucial to keeping your company protected and ensuring your milestones are met.

Your in-house counsel might not have the time or manpower to carefully review a trial’s informed consent forms before signing off on them. The attorneys at Contracts Associates can provide the additional assistance you need, on an as-needed basis. We can help you stay on schedule and ensure compliance with informed consent requirements. There’s no better plan than to have informed consent contracts reviewed quickly and thoroughly by experienced industry professionals like us.

Implications of Form 483

It’s important to keep in mind that Form 483 does not constitute the final Agency determination of whether cited conditions are absolute violations of the FD&C Act. Form 483 is a factor for consideration, along with all evidence or documentation collected on-site, and any responses made by the company. Only then does the FDA make a final determination as to what future actions might be necessary.

Proactive approaches with Contracts Associates

At Contracts Associates, we work with sponsors to ensure their clinical trials don’t fall behind schedule or expose the company to undue risk. We can even produce and maintain a personalized “risk register” for you, complete with contract terms and other matters that we become aware of in our reviews—helping you avoid future problems.

Our extensive industry experience means we don’t require training—or the time, cost, and effort associated with a learning curve. We provide quick and meticulous turn-arounds, and can help you meet your milestones. Contact us today to find out how we can help you.

More Clinical Trials in China in the Future?

The China Food and Drug Administration (CFDA), which became a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in June 2017, is now moving forward with the implementation of several ICH guidelines in order to further the development of innovative drugs and devices in China, and align with global regulatory standards in manufacturing and development.

China’s implementation of the ICH guidelines will not only help ensure that global standards of quality and safety are met but can help reduce drag on pharmaceutical companies’ timelines by streamlining various processes such as clinical trial application and approval. Additional reforms will likely increase the number of Chinese hospitals and research centers able to manage clinical trials without having to undergo an extensive certification process.

These ICH-driven reforms will likely provide US pharmaceutical companies with greater opportunities to include China in global clinical research as well as greater access to the Chinese markets. As a member of ICH, China will be expected to continue implementing regulatory requirements for the manufacture and testing of study drug products. We expect to see an uptick in the conduct of clinical trials once the controls are in place to ensure that quality, safety, and efficiency is consistent across the Chinese markets.

We at Contracts Associates are looking forward to the further integration of China’s prominent researchers into our global clinical trials.