True or False:

(1) eSource in clinical trials means eliminating the possibility for transcription errors.

(2) Data collected in Electronic Data Capture (EDC) systems is eSource.

Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.



FDA Guidance on eSource in Clinical Investigations
FDA defines eSource as *any* data initially recorded in electronic format. That’s a broad definition, one that includes:
     a) equipment-generated data, such as digital imaging and labs
     b) electronic Patient Reported Outcome (ePRO) transmissions
     c) data streams from mobile health devices, such as Apple ResearchKit
     d) data entered directly into an EDC, known as Direct-Data-Entry (DDE) solutions
     e) data entered into an Electronic Health Record (EHR) or electronic Medical Record (EMR) system


Discussion of Direct-Data-Entry (DDE)
DDE systems allow research staff members to use portable devices to enter study data directly into an EDC system. DDEs have been garnering a lot of industry attention of late, and a number of companies offer solutions that offer a DDE data flow. As independent 3rd party auditors, we don’t want to play favorites by mentioning specific systems as examples, but if your company sells or uses a DDE system that you want to highlight, feel free to add a comment below to give it a shout out.

Discussion of EMR/EDC Integration
Not long after finalizing its e-Source guidance, FDA hosted a webinar that encouraged companies to explore direct EMR/EDC integration. While a few industry players have taken up the effort, movement has been slow. One difficulty: generally EMRs are built with healthcare in mind, not clinical research. Secondly, with so many EMR and EDC vendors, ensuring that EMR data from one system is mapped to appropriate EDC fields in another system relies heavily on data standards that are still being defined and need to be implemented on both sides. 

Source Data Verification (SDV)
If data is transmitted directly from the source system to an Electronic Data Collection (EDC) system, SDV is not required, since the source data isn’t being transcribed manually. (Note: other types of Source Data Review (SDR) activities are still necessary, even if SDV isn’t. SDR must be conducted to verify ALCOA-C data principles such as attribution, originality, accuracy, completeness, etc.) Direct transmission from source system to EDC system is the typical pathway for items (a) – (d) above, and so SDV is not required for these types of eSource.


Common Confusions
SDV. Unless there is EMR/EDC integration – Item (e) above – source data from an EMR system needs to be manually transcribed. This is what makes T/F question #1 false. Just because source data originates in an EMR, it does *not* suggest SDV checks are superfluous. You could argue, as many have, that SDV is not a high-value activity and uncovers only a small percent of data error. That argument may well influence how much SDV is conducted, but whenever data is transcribed from original source into an EDC system, SDV is a relevant discussion.

EDC Data. It’s not unusual for someone to refer to data stored in EDCs as eSource. Data stored in EDCs are electronic, and may be source, but only if the EDC is the first place the data is recorded. This is what makes T/F question #2 false.

In Summary
If you’re ever in a discussion about eSource and things start going sideways, it may be time to haul out the formal definition of eSource -- in all its tedious detail -- to make sure everyone is using the term the same way. 

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Image Credit: Paradox by Brett Jordan

Trying to comply with the GDPR got you down?
Maybe our parody will cheer you up.

(Sung to the tune of Lennon-McCartney's "Back in the U.S.S.R.")

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

______________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?

A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.

This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.

Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)

So here it is. Here’s what she said...

Clinical research sites rely heavily on technology to store and manage study data, so regulators are focusing on computer systems and electronic data more than ever before. Many of the systems – such as Electronic Data Collection (EDCs), Interactive Response Technology (IRTs), and e-diaries – are selected and largely controlled by sponsors, CROs, and/or third-party vendors. That doesn’t mean, however, that site staff won’t be expected to answer questions about these systems during a regulatory inspection. Quite the contrary: site personnel are responsible for the integrity of the data these systems house. They need to be able to demonstrate the knowledge required to meet their regulatory obligations.

No one is expecting site staff to be computer specialists; the expertise on these systems resides within the sponsor/CRO/vendor organizations. But the better a site can satisfy a basic, frontline inquiry into the systems it uses, the less likely it is that an inspector will pursue additional lines of questions.

So how can sponsors and CROs help?

They can provide a set of short summaries (one page per system) that answer the questions regulators are likely to ask site staff members. Filed in the Investigator Site File (ISF), ready for use, these summaries will be valuable resources.


The Basics

First, sponsors/CROs should supply identifying information: the name of the system, the vendor, the version of the system currently being used, and a few sentences that describe what the system does.
User Access and Control

To ensure both data integrity and compliance with Part 11 e-record/e-signature regulation, it’s essential that access to a system be controlled and data entry/updates be traceable to a specific person. To that end, the one-pager should describe how unique logins are assigned and how users are restricted to activities appropriate to their roles in the study. A monitor requires read-only access to an EDC system. A study coordinator needs to be able to enter and change EDC data. A Principal Investigator must be able to sign electronic Case Report Forms (CRFs). The role determines the access. Staff should also be able to briefly describe how an audit trail captures metadata that show what data were entered/altered, by whom, and when. (And someone, though not everyone, needs to be able to demonstrate how the audit trail can be used to piece together the “story of the data.” That, however, is too much to ask from our one-pager.)

Validation 101

It would be unusual for site personnel to have detailed knowledge of Computer System Validation (CSV) activities. Nevertheless, the one-pager could include a single line that confirms that the system was validated and by whom. A contact number could be included in case a regulator asks for more information or wants to see validation documents.

Where’s The Data?

Regulators will often ask where system data are stored. The answer to that question can be a simple sentence: The data are hosted by the EDC vendor at such-and-such location, or stored at the CRO, or sit on a local server within the site’s IT department.

Finally, the last line of our one-pager could be a simple statement prepared by the sponsor, CRO, or vendor, confirming that the data are protected wherever they are being stored. The data center is secure and environmentally controlled; the data are backed up to protect against loss; the system is accessed via the web through an encrypted channel -- whatever protections apply.

Conclusion

Regulators are increasingly focused on the integrity of study-related data, and that means added scrutiny of electronic systems and records. More inspections are being conducted mid-study so regulators can evaluate and ask about live systems in current operation. It’s very difficult for sites to field these questions without help from the organizations who make the decisions and have the expertise.

It’s okay to tell an inspector, “I don’t know.” (And it’s always preferable to admit that than to improvise an answer.) But say it too many times, and it casts doubt on a site’s ability to produce and maintain reliable study data. That’s in no one’s interest.

It shouldn’t be overly burdensome to develop a one-page summary sheet for each system so site personnel can address an inspector’s questions on the spot. The Investigator Meetings or Site Initiation Visits would be a good opportunity for sites to raise this point with their sponsors/CROs.

Lisa Olson will be giving an encore presentation of “Developing a Part 11 Compliance Plan in Clinical Research,” on March 24th. She describes all the elements that regulators and clients will be expecting, and since sponsors and CROs can’t implement everything all at once, Lisa prioritizes the activities necessary for developing your plan. You can register for the online course, sponsored by the Life Science Training Institute, here. Use the promotion code olson to receive a 10% discount.

Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*.  In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own.

Our Favorites Tips from MAGI

So how does a clinical trial tip earn a spot on our exalted Faves List?  First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.

So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:

• To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful.
  
  
• After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.
  
  
• As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study.  Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.
  
  
• CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly.
  
  
• Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.
  
  
• CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.

Additional Tips from Polaris QA/Compliance Auditors

The MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.

• When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.
  
  
• Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:
  
  
• The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.
• The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.
  
  
• Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.
  
  
• There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:
  
  
• To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).
• When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.
• Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**

Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.

________________________________________________________________
 * Journal of Clinical Research Best Practices, July 2019

** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense.

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…

The nation’s largest pharmacy serving elder care facilities will pay Massachusetts nearly half a million dollars to settle allegations that it got kickbacks more than eight years ago from Abbott Laboratories to promote the anti-seizure drug, Depakote. The settlement was signed by Omnicare, a pharmacy services company that was acquired by CVS Health Corporation (NYSE: CVS) in August 2015. The $476,216 payment to Massachusetts is part of a $28 million multi-state settlement that included 47 states…

Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…

Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million…

On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…

Today, Shire plc confirmed it won’t make any new investments from Baxalta Ventures, the short-lived venture capital arm of the drug company Shire acquired in June.

The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…

On Thursday, Harvard University will open a 15,000-square-foot life science lab in Allston named after Steve Pagliuca, and executive at Bain Capital and co-owner of the Boston Celtics. The Pagliuca Harvard Life Lab will be the home to 20 startup ventures founded and run by Harvard faculty, alumni, students, and postdocs. The first 17 of those were revealed by the university a couple weeks ago, and they include drug and vaccine developers as well as DNA sequencing companies. Mayor Marty Walsh will…

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

Do we ever learn from our past mistakes? For many years we believed that technology was an inevitable force for good. It would give us instant access to a near infinite amount of information and allow us to easily and instantly connect with nearly anyone on earth. What could go wrong? The answer is that...

Click here to continue reading...

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

Top-line: The Congressional schedule and work practices are uncertain over the next few months, leaving many questions about whether and how appropriations bills will move forward. There is a possibility that increased funding at public health agencies, including FDA, may be exempt from FY 21 budget caps. The Alliance’s meeting with Dr. Boon, FDA Associate Commissioner […]

The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […]

Top-Line: There is no new information about the appropriations schedule for Congress. The House will require a rules change for appropriators to work remotely. The death of former FDA Commissioner Donald Kennedy is noted. More on FDA’s extraordinary efforts to address food safety and supply issues. Eventually, Congress will need to address FY 21 funding and […]

Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […]

Top-Line: This week we look at House and Senate schedules for returning to DC and starting on the FY 21 appropriations process. This week’s Analysis and Commentary explores the reasons why advances in science and technology foretell that FDA will need significant additional funding in FY 21. This column focuses on vaccine development. Senate Returns […]

FDA — along with NIH, CDC, and other front-line public health agencies — is caught up in the urgent COVID-19 efforts. Appropriately, enormous resources are being devoted to fighting the pandemic and more funding will come, if needed. At the same time, we are getting positive reports on the FDA’s efforts to carry out the […]

Top-line: Congress is inching forward on the FY 21 appropriations process. However, neither the House nor the Senate has adopted rules permitting virtual committee mark-ups. Also hanging over the process is the tight budget ceiling for non-defense discretionary (NDD) programs. Various ways it might be solved and implications for FDA are discussed in this week’s Analysis […]

WASHINGTON, D.C. – Co-Chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G. K. Butterfield (D-NC), applaud the passage of the Senate companion to their bill – S. 292, the Childhood Cancer STAR Act.

The STAR Act passed the House today by a unanimous vote.  It addresses the four major concerns facing the pediatric cancer community: Survivorship, Treatment, Access, and Research, and will elevate and prioritize the fight against childhood cancer at the National Institute of Health (NIH).

The members released the following joint statement:

"Today was a long anticipated day for the pediatric cancer community, and one to be celebrated.  This bill is the most comprehensive childhood cancer bill to ever pass Congress and will finally head to the president’s desk to be signed into law. Childhood cancer remains one of the deadliest killers of our kids and we as a Congress, and a nation, must say, ‘Enough is enough.’  As co-chairs of the Childhood Cancer Caucus, we would like to thank all those who made this possible, including the Alliance for Childhood Cancer and the entire childhood cancer advocacy community.”

Click here to watch McCaul’s floor remarks ahead of the House passage of the STAR Act.

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

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Rick Bright confirmed as having left his position as director of BARDA as the agency provides aid to develop solutions for COVID-19.

The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service.