Life Science Compliance Update

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34 posts from July 2016

July 29, 2016

Ubl Gets Personal, Lays Out Vision for Future of PhRMA


PhRMA President and CEO Steve Ubl recently joined the Medium blogging website and penned his first post, "Health Care Veteran Gaines New Perspective." The post goes through the struggles his family experienced with chronic disease, and how they have shaped his approach to his role at PhRMA. This post is expected to be the first of many where he will dive into topics such as: PhRMA's policy solutions to deliver innovative treatments to patients, promise in the pipeline, and the biopharmaceutical industry's economic footprint, among many other issues.

Ubl opens his inaugural post by opening up about a phone call he received from his wife, a phone call that followed a presentation and was eerily similar to the content provided in the presentation.

Mere minutes after presenting that video [about a mom struggling with caring for a toddler with type 1 diabetes], my wife called to tell me our son, Chris, who had been suffering from fatigue, weight loss and unusual thirst, had just been diagnosed with type 1 diabetes. The moment bordered on surreal.

Ubl goes on to explain that he felt that he knew what patients went through every day: interacting with doctors, nurses, insurance companies, and the various other parts of the health care system. This experience made him realize "I really didn't have a clue about what it's like to care for someone with a chronic medical condition."

While Ubl notes that insulin has come a long way and that researchers continue to innovate and deliver more stable forms of insulin, "that's not the exciting part." He states that what he is "most passionate about" is what is coming. He notes that "America is on the cusp of a golden era of medical innovation" and that we "have the building blocks to revolutionize the treatment of costly and debilitating diseases like cancer and Alzheimer's disease."

Importantly, Ubl does not make this post entirely about him, or entirely about the past and the progress that PhRMA has made in being able to help patients. He places an emphasis on what needs to happen in the future, to ensure that the aforementioned "golden era" can become a reality. He states,

We need policies that make the patient a priority, improve how our health care system works and make it affordable. That's why my organization recently introduced new recommendations and solutions to ensure our policy environment continues to support delivering these innovative treatments to patients like my son.

One such suggestion is to modernize the process. Ubl recognizes that it "takes too long and costs too much to develop a medicine, test it and get it to patients." He believes that the Food and Drug Administration (FDA) should be "empowered to use the latest technologies and methods, such as biomarkers, real world evidence and patient-reported outcomes." Such a process would "speed the delivery of innovative treatments to patients, enhance competition and keep costs down."

Ubl also believes that communication with payers would help to get more value out of health care. He notes that the prohibition of discussions between insurance companies and biopharmaceutical companies about medicines that are on the horizon gets in the way: it "doesn't give insurers the opportunity to plan their budgets, causing uncertainty about insurance premiums and other planning tools." If those barriers were removed, "efficiency and affordability" would be promoted, and it would help to ensure that "the right drug is getting to the right patient at the right time."

Along with many other health care professionals, Ubl does believe that a "well-informed consumer is an engaged and empowered patient." He believes that the information that should be made available to patients isn't so much the information provided in the so-called transparency effort by the Sunshine Act, but instead, in making the following types of information accessible to patients: is the physician or hospital they visit in network? Is the medicine they need covered, or are all medicines for their disease placed out of reach by the health plan?

Lastly, Ubl noted that market distortions need to be addressed, that "the U.S. health care system is largely market-based and has worked well over time, but more can be done to help it work even better." Items to be addressed here include the 340B program and risk adjustment programs. He believes that "helping the market work at its best can help preserve the safety net and improve affordable access to medicines for patients."

While showing such a raw side of himself, Ubl put a personal face on the PhRMA industry. We are hopeful that these blog posts will continue in a positive way forward: showing that the industry is there to support patients, not take advantage of them.

The Olympus Settlement – What It Can Tell Us About the Compliance Officer


When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement, however, provides us a rare glimpse into the nature of the Compliance Officer himself and how that can affect matters.

In March, we reported that medical equipment giant Olympus Corp. of the Americas (OCA) and its Miami- based subsidiary Olympus Latin America (OLA) had reached a settlement with the Department of Justice to pay a combined $646 million in civil awards and criminal penalties to the federal and various state governments, and reform its compliance program. The settlement is the largest ever for a medical device manufacturer accused of violating the Anti-Kickback Statute.

Read Full Article in the July 2016 Issue of Life Science Compliance Update

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July 28, 2016

FDA Guidance Data Integrity and Compliance With CGMP

In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA's ability to protect the public health. These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise is that cGMP sets forth minimum requirements to assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, strength, quality, and purity. To address these concerns, FDA has recently released a guidance on data integrity.

The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to cGMP records, as well as recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records (MPCR) are monitored and can only be used by authorized personnel.

Guidance Questions and FDA Answers

Addressing whether it is permissible to exclude cGMP data from decision making, FDA states any data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria and maintained for CGMP purposes. Electronic data generated to fulfill CGMP requirements should include relevant metadata. To exclude data from the release criteria decision-making process, there must be a valid, documented, scientific justification for its exclusion (see the guidance for industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production). The requirements for record retention and review do not differ depending on the data format; paper-based and electronic data record-keeping systems are subject to the same requirements.

FDA also recommends implementing appropriate controls to manage risks associated with each element of the system. Controls that are appropriately designed to validate a system for its intended use address software, hardware, personnel, and documentation.

To restrict access to CGMP computer systems, exercise appropriate controls to assure that changes to computerized MPCRs, or other records, or input of laboratory data into computerized records, can be made only by authorized personnel. FDA recommends restricting the ability to alter specifications, process parameters, or manufacturing or testing methods by technical means where possible (for example, by limiting permissions to change settings or data). FDA suggests that the system administrator role, including any rights to alter files and settings, be assigned to personnel independent from those responsible for the record content. To assist in controlling access, FDA recommends maintaining a list of authorized individuals and their access privileges for each CGMP computer system in use.

Regarding audits, FDA recommends that audit trails that capture changes to critical data be reviewed with each record and before final approval of the record. Audit trails subject to regular review should include, but are not limited to, the following: the change history of finished product test results, changes to sample run sequences, changes to sample identification, and changes to critical process parameters. FDA recommends routine scheduled audit trail review based on the complexity of the system and its intended use.

Additionally, audit trails are considered part of the associated records. Personnel responsible for record review under CGMP should review the audit trails that capture changes to critical data associated with the record as they review the rest of the record. For example, all production and control records, which includes audit trails, must be reviewed and approved by the quality unit. This is similar to the expectation that cross-outs on paper be assessed when reviewing data.

FDA explains that an electronic data becomes a CGMP record when it is generated to satisfy a CGMP requirement. Document or save the data at the time of performance to create a record in compliance with CGMP requirements. FDA expects processes to be designed so that quality data required to be created and maintained cannot be modified. For example, chromatograms should be sent to long-term storage (archiving or a permanent record) upon run completion instead of at the end of a day's runs.

FDA says it is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook. Similarly, it is not acceptable to store data electronically in temporary memory, in a manner that allows for manipulation, before creating a permanent record. Electronic data that are automatically saved into temporary memory do not meet CGMP documentation or retention requirements.

A combination of technical and procedural controls can also be employed to meet CGMP documentation practices for electronic systems. For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system, can be designed to automatically save after each separate entry. This would be similar to recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements. The computer system could be combined with a procedure requiring data be entered immediately when generated. For PET drugs, see the "Laboratory Controls" section of the guidance for industry PET Drugs — Current Good Manufacturing Practice (CGMP).

Finally, FDA addresses recommendations regarding data integrity problems identified during inspections, in warning letters, or in other regulatory actions. FDA encourages demonstrations of effectively remedied problems by: hiring a third party auditor, determining the scope of the problem, implementing a corrective action plan (globally), and removing at all levels individuals responsible for problems from CGMP positions. FDA may conduct an inspection to decide whether CGMP violations involving data integrity have been remedied.

These expectations mirror those developed for the Application Integrity Policy. For more detailed guidance, see the "Points to Consider for Internal Reviews and Corrective Action Operating Plans" public document available on the FDA website.


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