HHS/FDA Proposed Deregulations: Recommendations for HIPAA and IRB’s approval and informed consent process

The US Executive Branch’s  Spring 2019 Unified Agenda of Regulatory and Deregulatory Actions is out, and HHS/FDA have identified for deregulation, among other things, the current IRB approval process in order to allow any U.S. clinical site to rely on the approval of just one IRB in order to conduct a study at that site.  All proposed rule changes were made by the agency in response to the Administration’s request for all agencies to identify “ineffective regulations” and propose deregulations to meet the Administration’s objectives to streamline and improve “cost effectiveness” (although it is not clear whether it is HHS that would see economic benefit).  

Institutional Review Board Proposals

  • Title: Institutional Review Boards; Cooperative Research 
    • Abstract: This proposed rule would replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research would need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions.  This proposed rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.

  • Title: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
    • Abstract: This proposed regulation would permit an Institutional Review Board (IRB) to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This proposed regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs.

Health Insurance Portability and Accountability Act of 1996 (HIPPA) Proposals

Also proposed is the “removal of barriers” created by HIPAA compliance, which is especially interesting in light of the fact that, in 2018, the Office of Civil Rights set an agency record in HIPAA enforcement activity by levying fines totaling $28.7 million (against MD Anderson, Boston Medical Center and Brigham’s and Women’s Hospital and MGH, among others).   All proposed rule changes were made by the agency in response to the Administration’s request for all agencies to identify “ineffective regulations” and propose deregulations to meet the Administration’s objectives to streamline and improve “cost effectiveness” (although it is not clear whether it is HHS that would see economic benefit).

  • Title: HIPAA Privacy; Changes to Support, and Remove Barriers to, Coordinated Care
    • Abstract: This proposed rule would publish for comment proposals to modify provisions of the HIPAA Rules which present barriers that limit or discourage coordinated care and case management (including care coordination challenges arising from the opioid crisis) among hospitals, physicians (and other providers), payors, and patients, or otherwise impose regulatory burdens that may impede the transformation to value-based health care without providing commensurate privacy or security protections for patients’ protected health information (PHI) and while maintaining patients’ ability to control the use or disclosure of their PHI and to access PHI. This proposed rule would subsume the previous 0945-AA09 entry in the Regulatory Agenda.

Other HHS/FDA Proposals

The Office of Management and Budget’s Office of Information and Regulatory Affairs website has a synopsis of each regulation identified for “deregulation” by HHS/FDA, but the links to the meeting minutes for each proposal are inactive and the webpages with proposals under the Fall 2018 Unified Agenda are no longer active on the FDA website; it is not possible at this time to substantively review and compare the data (some of the HHS Spring 2019 proposals are updates to 2018 proposals) via the web.  Below is a list of changes we’ll be tracking as more information is made available as part of the public comment period:

  • Title: Definition of the Term “Biological Product” 
    • Abstract: The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (21 U.S.C. 262) adopted in the Biologics Price Competition and Innovation Act of 2009. 
  • Title: ●HHS Policy for the Protection of Human Research Subjects: Update to Subpart E (IRB Registration) 
    • Abstract: This rule would amend subpart E of 45 CFR part 46 (Institutional Review Board (IRB) Registration) to align subpart E with recent amendments to the basic HHS Policy for the Protection of Human Subjects (subpart A of 45 CFR part 46, also known as the Common Rule) and to give effect to one of the policy goals of the subpart A revision (i.e., eliminating unnecessary administrative burden on IRBs and institutions regulated under 45 CFR part 46). The general compliance date of amendments to subpart A of 45 CFR part 46 was January 21, 2019.
  • Title: Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards
    • Abstract: This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, several sections certain provisions of FDA’s regulations on human subject protection and institutional review boards with the recently revised “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR 46, subpart A)). The rule also proposes minor amendments to related regulatory provisions.
  • Title: Updates to 1974 Privacy Act Regulations
    • Abstract: This rulemaking will update regulations at 45 CFR part 5b, which detail how the Department implements requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a).

Public Review is Open for Comment: ICH Draft Revision of Guideline on General Trial Design and Conduct

The draft 2020 ICH(E8)R1 is three times the length of the original and is available for Sponsor comment. The ICH has taken its many years of data and identified principles which, among other things, will facilitate the acceptance of sponsor data worldwide, help ensure subject recruitment by involving subjects in study design and placing an emphasis on quality at every step of a trial.

Patient Input into Study Design

Patient organizations have already weighed in the updated Guideline reflects this critical input. Designing a study which fits the patients’ lifestyle (considering their disease state), will ensure that the drug itself will be better tailored to the population that will actually use the drug, post-approval.  From ICH(E8)(R1) 2.3:

“Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment, and promote adherence, which should continue throughout the duration of the study. Patients also provide their perspective of living with a condition, which contributes to the determination of endpoints that are meaningful to patients, selection of the right population, duration of the study, and use of the right comparators.”

Investigator Input into Study Design

ICH(E8)(R1) offers very early-stage study planning guidance and, not unexpectedly, it has found that reliance on just a few key opinion leaders for study design has to be augmented by opening the study to challenge by other subject matter experts: subjects and the potential investigators. From ICG(E8)(R1) 3.3.3:

“Clinical investigators and potential study subjects have valuable insights into the feasibility of enrolling subjects who meet proposed eligibility criteria, whether scheduled study visits and procedures may be overly burdensome and lead to early dropouts, and the general relevance of study endpoints and study settings to the targeted patient population”

Create a Sponsor Culture that Supports Open Dialogue

Interestingly, the ICH has identified a critical Sponsor success factor as “Establishing a Culture that Supports Open Dialogue” [ICH(E8)R1, 3.3] by rewarding team and individual critical thinking and encouraging open dialogue to go beyond “reliance on tools and checklists”. From the Guideline:

“Choose quality measures and performance indicators that are aligned with a proactive approach 169 to design. For example, an overemphasis on minimising the time to first patient enrolled may result in devoting too little time to identifying and preventing errors that matter through careful design.”

And:

“Study designs should be operationally feasible and avoid unnecessary complexity and unnecessary data collection. Patient consultation early in the study design process contributes to these factors and would be likely to result in fewer protocol amendments.”

Deemphasize Factors Such as First-Patient-In

The Guideline suggest that shifting team focus onto high-level quality goals in the planning stages, as opposed to micro-goals tied to enrolment, will contribute to overall study success:

“Choose quality measures and performance indicators that are aligned with a proactive approach to design. For example, an overemphasis on minimising the time to first patient enrolled may result in devoting too little time to identifying and preventing errors that matter through careful design.”

And:

“Consider whether nonessential activities may be eliminated from the study to simplify conduct, improve study efficiency, and target resources to critical areas.” [ICH(E8)(R1) 3.3.2]

Guidance on Operational Criteria

The Guideline provides Sponsor guidance to help achieve another critical success factor:  proactive, routine communication of changing study priorities and ongoing risks mitigation activities to its study sites, as site understanding of priorities and necessary resource allocation will enhance the correct implementation of a study protocol (ICH E8(R1). One possible solution would be implementation of sub-program management team, with an emphasis on crafting routine communication to update investigators on the changing study priorities (outside of the Protocol) and any operational issues such as drug availably, delays in safety reporting by other study sites and whatever else a sponsor may think a site needs to know to increase its investigators knowledge of the drug.

The draft is currently under public consultation. Stakeholders may submit comments or questions to step2comments@ich.org

Read the draft guideline here: https://bit.ly/2Jyzzjl

 

Clinical Trial Data Transfer In The Aftermath Of No Deal Brexit

Quick Refresher: As established by the EU GDPR when it first took effect in May 2018, any company that handles the data of any EU citizens – whether or not that company is based in the EU – must adhere to stringent GDPR regulations regarding data privacy and protection.  Data can include anything from name, email address, medical information or biospecimens. But now that the UK is withdrawing from the EU and no longer covered by the GDPR as an EU Member State, what does that mean for data privacy and the flow of clinical study data, such as adverse events reports, samples and central lab data?

What Happens to Data Protection Services and Appointment of UK Entities as Sponsor Representatives under GDPR?

Amidst the many uncertainties raised by a hard Brexit, questions exist as to what steps US sponsors should take to ensure their study data continues to move across borders without interruption – in particular, whether the current data representative services agreements with their CROs will be, well, moot or functional after Brexit. We at CA have noticed that many of the CROs party to our client’s data representative services agreements (agreements by which one engages a CRO to perform a sponsor’s EU data controller obligations and appoints the CRO to be its EU DPR under the GDPR) enter into them using their UK entities. Questions about the validity of these agreements will not be definitively answered until after the UK strikes a deal with the EU, or, alternatively, the UK crashes out of the EU with no deal. For now, the sponsor can only attempt to prepare and plan for any possible Brexit outcome as the future is unknown.  It is clear that no US sponsor study data can be processed in the EU without a validly appointed data protection representative (again, this appointment is a longstanding EU and now a GDPR requirement for US sponsors with no EU presence), but it is not clear whether or not the remaining EU member states will accept or recognize the appointment of a UK CRO.

Remember, the UK will still need to comply with GDPR, even though it’s no longer a member state of the EU due to GDPR’s extraterritorial reach. However, in the absence of a Brexit deal, the UK will become a “third country” and will be tasked with proving to the EU that its data protection laws (the UK Data Protection Act, more below) are “adequate”, or compliant with GDPR standards to allow for seamless data transfers to the UK from the EU.

A best practice for companies would be to carefully track the impact of Brexit on processing data of EU citizens in the next 50 or so days. The UK Information Commissioner’s office has published some helpful information. If it seems like the company’s data flows might be negatively impacted by a no-deal Brexit or the UK’s status as a third country with no adequacy rating, then the company should consider implementing contract-based mechanisms that would help mitigate any interruptions in data sharing. In some instances – but not all – certain contractual clauses could be drafted to allow data transfers from the EU to the UK. The EU model contact clauses, which can be used to amend existing agreements to ensure adequate, can be found on the European Commission website.

How does the UK Data Protection Act Differ from the EU GDPR?

The EU GDPR expressly allowed/encouraged the member states to pass local data protection legislation that augmented and worked in tandem with GDPR standards. Germany and the UK were two of the member states that had their local legislation at the ready and right away, the UK Data Protection Act of 2018 was passed. The UK DPA of 2018 Chapter 2 expressly adopts all GDPR definitions and supplements it, and Chapter 3 applies to certain types of “…personal data to which the GDPR does not apply (see Section 21), and makes provision for a regime broadly equivalent to the GDPR for such processing.”

Is the UK ready to amend its legislation to allow uninterrupted transfer of personal data after March 29, 2019?

Yes. The UK government has an existing Department for Digital, Culture, Media and Sport (we have nothing like this in the US, but we should!) and they have a legislative amendment ready to go. It seems as if the UK domestic law will preserve GDPR standards, by amending the UK DPA of 2018 so that “obligations and rights that organisations and data subjects have become familiar with will stay the same”.  It also appears likely that the UK will deem all EU Member States and EEA countries as “adequate” – a rating meaning that the territory employs an appropriate or “adequate” level of data protection safeguards – with the hope that the data flows between the UK and the EU and EEA countries will continue with minimal disruption.

The new legislation is called the “EU (Withdrawal) Act of 2018 (EUWA) and it will retain the GDPR in UK law and make changes necessary to ensure that the UK obtains the “adequacy decisions” its businesses and its government (law enforcement and security agencies need to transfer data too) will need to continue to function after March 29, 2018. EUWA is not final but the technical notice it filed in September 2018 was encouraging in that it anticipates “no deal” and therefore could actually be functioning on Day 1. See, “Data Protection if there’s no Brexit deal”.

Contracts Associates is prepared to help your company successfully navigate the possibility of a no deal Brexit. Our team of attorneys will work to 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 contact our office with any questions at 781-598-8000 or by emailing our CEO, Colleen Sproul, at cms@contractsassociates.com

 

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!