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!
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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.
UPDATED JANUARY 22, 2018: Implementation of the Common Rule is Delayed for Six Months
Updated January 22, 2018: HHS and fifteen other federal departments and agencies have delayed implementation of the revised Common Rule for six months. Originally set to take effect on January 19, 2018, the effective date and compliance deadline have been deferred until July 19, 2018.
The delay will provide institutions with at least six months to prepare for eventual implementation and compliance with the 2018 requirements—which might come as welcome news to those who were unprepared to meet the original deadline.
Currently, HHS and the fifteen other agencies are working toward a proposal to even further delay implementation of the revised Common Rule and will be seeking feedback and public comment via the rulemaking process.
Contracts Associates will continue to monitor the status of the revised Common Rule very carefully and will update this blog with any important new insights. If you have any questions about the changes, we encourage you to contact our office at 781-598-8000 or email our CEO, Colleen Sproul, at cms@contractsassociates.com so that we can provide you with the most current information regarding changes and compliance.
[Originally Published on January 4, 2018] The U.S. Department of Health and Human Services (HHS) has proposed a one-year delay in implementation of the revisions to the Common Rule. The updated rule was set to take effect on January 19, 2018 with compliance expected on the same date. But, as of this writing, the effective date and the applicability of the revised Common Rule is uncertain.
During the waning days of the Obama administration, the final text of the updated Common Rule was released by HHS. Upon entering office, the Trump administration immediately froze all new or pending regulations left over from the previous administration to allow them to be reviewed by the new President’s appointees. Implementation of the Common Rule changes was accordingly placed on hold.
What are the Revisions to the Common Rule?
The Common Rule, or the Federal Policy for the Protection of Human Subjects, is a set of regulations governing federally-funded research involving human participants, their data and biospecimens. First promulgated in 1991 and not updated since 2005, HHS proposed updating the Common Rule to reflect the rapidly-changing research landscape, especially in terms of human subject data and advancing digital technologies.
The revision process began in 2011 with the goal of enhancing protections of participants (relative to informed consent and data) and reducing administrative burdens. The Common Rule underwent significant revision with informed consent provisions requiring “a concise and focused presentation of the key information” in contracts. The updated rule also requires informed consent provisions to explain, among other things, the purposes of the research, risks and benefits of participation, and any appropriate alternatives so that a “reasonable person” can more easily decide whether or not to participate in the research.
In addition, the new rule requires that a version of the consent form that was used for enrollment purposes for each clinical trial be posted to a federal website. It also allows for gaining broad consent for secondary research use of identifiable data and biospecimens of participants.
So What Happens Next?
The Office of Management and Budget (OMB) is currently reviewing the proposal by HHS to delay implementation and compliance by one year. Along with the one-year delay, HHS is considering allowing three burden-reducing provisions to be implemented during the delay to ease administration. Precisely which three provisions remains unclear as they have not been specifically enumerated and the proposal currently exists as a title with no accompanying text.
It is unclear whether both the effective and compliance date would be pushed back, or only the compliance date, or whether there will be no changes at all and the new rule will be fully implemented on January 19, 2018. The possibility of delay in compliance might be seen as good news to some institutions who are unprepared to comply with the new rule and need time to make necessary changes. But as of now, the future of the revised Common Rule is unknown.
Contracts Associates will continue to monitor the status of the revised Common Rule very carefully and will update this blog with any important new insights. If you have any questions about the changes, we encourage you to contact our office at 781-598-8000 or email our CEO, Colleen Sproul, at cms@contractsassociates.com so that we can provide you with the most current information regarding changes and compliance.
U.S. Clinical Trial Sponsors Are Unprepared for New EU GDPR Regulation
As of May 25, 2018, U.S. sponsors of clinical studies conducted in the European Union must be in compliance with the EU’s new General Data Protection Regulation (“GDPR”) or risk the possibility of significant fines.
U.S. sponsor companies must contend with this new EU regulation and the learning curve will likely be steep—especially as the GDPR requirements contrast sharply with the U.S.’s lack of any meaningful privacy regulation.
Companies found to be in non-compliance with the GDPR risk significant fines – possibly up to 4% of total worldwide annual turnover of the preceding financial year or 20 000 000 EUR, whichever is larger. The GDPR applies to the processing of personal data which includes subjects’ names, addresses, medical information, and more—regardless of whether the processing takes place in the EU or not.
We expect that our clients will be particularly impacted by the provisions related to the stringent, new contractual Informed Consent requirements for terms concerning use of bio specimens.
The GDPR also mandates the appointment of a senior-level Data Protection Officer with expertise in data protection law. This DPO will report directly to a C-suite executive. The law also requires companies to comply with certain processes for data protection and data management.
Contracts Associates is prepared to help your company successfully navigate this new regulatory framework. Our team of attorneys can help minimize the risk of penalties by updating your contracts to ensure that all informed consent language is GDPR-compliant with regard to sample and data usage. We will help your company uphold its legal duties and obligations to EU sites and vendors by drafting new contract template terms as needed. We encourage you to start your GDPR-compliance planning by contacting our office at 781-598-8000 or emailing our CEO, Colleen Sproul, at cms@contractsassociates.com
FDA suddenly adds four-letter meaningless suffixes to new biologics’ nonproprietary names
Back in 2015, the FDA implemented a policy which required the addition of suffixes to biosimilars. On June 1 2016, the FDA suggested that sponsors could provide the FDA with up to 10 preferred proposed suffixes for its biosimilars and that the FDA would then choose which preferred suffix met its guidelines. Sounds like a good policy, right? Companies get to suggest their favorite “baby” names and the FDA picks one it likes. Well, the FDA withdrew that plan on June 20, 2016.
However the suffixes for biosimilars have been chosen since June 2016, it was clear that the FDA only applied this requirement for suffixes (which makes sense for biosimilars, so that consumers can tell them apart and doctors can report adverse events) to biosimilars. For example, Sandoz’s Zarxio’s nonproprietary name is “filgrastim-sndz”. Totally logical so far.
On November 16, 2017, the FDA approved Genetech’s hemophilia A biologic Hemlibra (good news for patients!) and assigned it a random suffix of “kxwh” (emicizumab-kxwh). In the absence of published public comments (which would be published in the Federal Register) and/or the announcement of a policy decision, one has to assume that assigning these suffixes to all new biologics will be the law of the land.
We know the time an effort industry sponsors put into branding their biologics and we imagine that random characters appended to the end of such a carefully-considered name is not the most welcome of surprises. The FDA typically provides sponsors with substantial notice prior to making substantive policy changes (it is a government agency after all!); however, this sort of abrupt implementation of policy may be our new normal.
Obama’s Department of Justice recovers staggering amount of money from Health Care industry
The 2016 numbers are in, and the health care industry (which includes life sciences companies) had to pay out a total of $2.5 billion (more than half of the total $4.7 billion recovered in 2016) in settlements and judgements from civil cases which involved fraud and false claims against the government. Wyeth and Pfizer, Inc. paid $784.6 million of the $2.5 billion; the payments were made to the federal government and to state Medicaid programs.
What I found most remarkable about the DOJ report was that 60% of all funds recovered by the DOJ in last 30 years under the False Claims Act ($55.17 billion), was recovered between fiscal years 2009 and 2016. This begs the question: Why did the Department of Justice under the Obama administration recover $31.3 billion of the total $55.17 billion recovered by the DOJ between 1986 and 2016? Is it the only administration to actively enforce the law and investigate healthcare fraud, housing and mortgage fraud, and fraudulent activities related to federal contracts and programs? Was there just an unprecedented amount of fraud and abuse during the Obama administration? Was President Obama’s Financial Fraud Enforcement Task Force (established in 2009)just incredibly effective?
The second question is: will the healthcare industry and its pharmaceutical and device companies will continue to pay the proverbial lion’s share of monies recovered by the new adminstration?
In case anyone wondered where the recovered funds are diverted to, according to the DOJ, “…The beneficiaries of these efforts include veterans, the elderly, and low-income families who are insured by federal health care programs; families and students who are able to afford homes and go to college thanks to federally insured loans; and all of us who are protected by the government’s investment in national security and defense. In short, Americans across the country are healthier, enjoy a better quality of life, and are safer because of our continuing success in protecting taxpayer funds from misuse.”.