Patient Safety & Product Quality
Patient Safety First
Patient safety has always and will always continue to be the focal point in our R&D program. We take great pride in our ability to discover and manufacture products with the hope and expectation that they will make a meaningful difference in the lives of patients like you; but this comes with the vital responsibility that to make a difference, we must look out for patients' well-being at every stage of the product’s development.
Safety in Clinical Trials
Patient safety is paramount in the way clinical trials are designed and carried out. We want to ensure that our studies are conducted in the highest ethical manner and in accordance with U.S. and international guidelines, including Good Clinical Practice (GCP) and the Declaration of Helsinki.
In addition to the required Governmental oversight, we implement our own checks and balances in the form of stringent internal committees for ensuring patient safety during Allergan-sponsored clinical trials. These committees include: the Pre-Clinical Group, which sets the high safety bar before an Allergan product ever reaches the first patient, and the Protocol Review Group, which ensures that regulated safety criteria has been met in the trials and that the patients being studied are appropriately informed of the risks that may come with using the product.
Next, when engaging patients to enroll in clinical trials, we begin with the Informed Consent process. The Informed Consent is a document which details patient rights, confidentiality and the potential risks associated with the drug being studied, to help the patient make the appropriate decision to participate, continue or disengage from the trial. We strictly adhere to this Informed Consent protocol, which is closely regulated by authorities both in the United States and internationally to preserve the rights of patients. For further reference, in case interested, the Department of Health and Human Services’ Office for Human Research Protection (OHRP) provides guidance for the Informed Consent process and lists some frequently asked questions.
Often times, we focus on trials that study vulnerable patient populations. In this event, Allergan may secure additional clinical experts in the field to make certain that the safety of these patients is never compromised while participating in the trial.
A list of Allergan’s current and past clinical trials can be accessed by visiting the U.S. National Institutes of Health’s Clinical Trials Web site located at www.clinicaltrials.gov.
Talking About Risks and Benefits of Our Products
Weighing Risk vs Benefit
The right medicine for the right patient can lead to significant improvements in the patient’s condition, disease or lifestyle. But all physicians understand that products are not without risk and that these risks must be clinically assessed and carefully weighed against the product’s potential benefits each time a patient is treated to help ensure the patient’s safety is put first and to help optimize the outcome for the patient. As a leading multi-specialty health care company, we invest significant resources into assessing the risk/benefit profile of each of our products before and after we bring them to market, developing product labels and educating physicians so they can help patients like you weigh the risks and benefits of treatments and determine what would be best for you. As a patient, you have a very important role to play in educating yourself on available treatment options and discussing the options and risks with your physician. You can find more information about all of Allergan’s products and their risk/benefit profiles here.
Responsible Business Practices
We take many factors into account when assessing the risk/benefit profile of a product. During clinical trials, study protocols are reviewed both within the company and by independent review boards to ensure they are acceptably designed for the stage of development, are based on sound medical science, and communicate to trial subjects both potential benefits and risks of participating in the study prior to their agreeing to take part. In addition, there is careful oversight of the safety of trial subjects during the conduct of the study. Once the results of the trials are available, Allergan next evaluates the benefit provided by the therapy in the context of any risks, and whether this risk-benefit relationship would be acceptable to patients and physicians, including a consideration of currently available therapies for the disease under study. It is also important that both risks and benefits can be appropriately communicated via the product’s label and/or other physician and patient information.
Not Just the Fine Print – Product Labeling
A drug’s label (or package insert) is a visible and accessible tool to help a physician determine whether a particular treatment’s risks outweigh its benefits and if an Allergan product is ultimately the right fit for a patient. Creating the label is in collaboration with regulatory agencies, such as the FDA and European authorities, a process that involves multiple departments at Allergan – including, among others, Research and Development, Quality Assurance, Regulatory Affairs, and the multiple committees that evaluate clinical trials – that are focused on providing physicians with accurate and up-to-date guidance regarding the risk/benefit profile of a product, so they can best advise their patients. In addition to detailing a drug’s approved uses or indications, the label helps define for the physician potential risks of treatment to the patient, including contraindications, warnings of possible serious side effects associated with the use of the product and a list of adverse effects observed in studies of the treatment. In essence, the label is a safety analysis that helps physicians make decisions regarding treatment of their patients. Once a product is on the market, our responsibility to safety does not end and changes can be made to the label if additional information is obtained once the product is in use. Updates to a product’s label stem from ongoing monitoring of the drug’s safety profile once on the market, which supplement the information obtained from registration clinical trials.
A Personal Decision
Weighing the benefits against the risks of a medication is a personal decision, and one that must be made between you and your doctor. Each treatment decision you make will be unique, as the risk/benefit relationship for a medical product may differ from patient to patient. Some patients may prefer to live with their disease or condition and decide to let it go untreated to avoid the potential of side effects, while others may find the risks to be acceptable given the possible benefit of improving their disease or condition with treatment. Additionally, a patient may deem the risk of certain potential side effects acceptable if a product is the only one available to treat a certain disease; however, it might be unacceptable to another patient and his or her physician if there are other treatment options available. Our responsibility is to provide patients with as safe and as high quality products possible, while also communicating the risks and benefits. It is a responsibility that is taken seriously and reflected in each function of our business; it is an infinite job to provide access to the health care you deserve.
Our Focus on Quality Throughout the Product Life Cycle
The Safety Complement
The quality of a particular drug, biologic or medical device is integral to the safety of the patient who uses it. We manufacture our products to the highest global regulatory standards. We use state-of-the-art technologies to ensure our products are of the highest quality and suitable for safe medical use. Our global network maintains this standard around the world.
Our focus on quality is ongoing—never static. We make continuous improvements to our manufacturing and production processes and exceed all regulatory guidance that governs the medical products in the United States and around the world. Ultimately, what drives our quality assurance (QA) program is a reflection of our safety-first culture—all measures aim to result in safe and beneficial experiences for patients.
The Allergan QA program focuses on the complete life cycle of our products, meaning that quality is evaluated from the product’s initial use in clinical trials through to its use in physicians’ practices.
Drugs and Biologics
The QA measures undertaken for our drugs and biologics complement the processes we use to ensure the quality of our medical devices. For our pharmaceutical products and biologics, the QA program begins with our product ingredients, includes the manufacturing and sterilization stage, and continues through use of the product by patient. Our particular methods of sterilization include both aseptic manufacturing, and terminal sterilization incorporating state of the art controls and the industry’s highest standards. Aseptic manufacturing requires precise attention at every step of the process to prevent even the slightest contamination of a product. Due to the precise nature of aseptic manufacturing, the process is governed by many different guidelines around the world, and although the standards in each country are different, we generally adhere to the most stringent ones.
Once our products are assembled post sterilization, they are subjected to a significant series of quality testing for each “batch” of product to assure and validate the quality of each batch. Our products are also subjected to a comprehensive stability program that tests the product throughout its shelf-life, over several years. Additionally, a specific risk analysis is developed for every product in advance of its entry into the market to ensure a patient’s experience with the treatment will be reliable, effective and most importantly, safe throughout the product’s life cycle.
For our medical devices, which are primarily implants or intra-dermal injections, there are several additional QA measures that are put in place to accommodate for the differences in manufacturing medical devices versus drugs or biologics and are specific to the regulatory requirements of each country where medical devices are made available to patients. Specifically, our approach utilizes what we call a “proof of process” compliance system that verifies specifications and validates each device as proscribed by regulatory authorities around the world. Allergan also tests its medical devices as part of a comprehensive risk/benefit analysis. Like drugs and biologics, our devices also are subjected to a series of rigorous quality testing – including physical and mechanical evaluations where appropriate. Device performance is monitored over the life cycle of the product and in some cases tracked on an individual patient basis.
If improvements can be made to our devices, both the QA and design teams work together to make certain that the quality and safety of the device will not be compromised. The work between the design and QA teams is a testament to an ingrained way of thinking we have at Allergan that never loses site of the bigger picture – your safety.
Quality In the Market
Once a product leaves the manufacturing plant, QA measures remain equally vigilant. The performance and quality of our products are continuously monitored once they are made available to patients and involve routine dialogue with physicians who use the products and the pharmacists who dispense them. However, counterfeit drugs manufactured and sold around the world pose great challenges to federal agencies such as the U.S. Food and Drug Administration (FDA) and Customs and Border Protection (CBP) under the Department of Homeland Security (DHS). Unfortunately, the unscrupulous and illegal attempt by some individuals or companies to market products that are not clinically tested for safety or efficacy, lack regulatory approval (and therefore unsuitable for medical use) at the expense of patients’ safety for purely financial gains is something that affects every pharmaceutical and medical device company. We are not immune to this risk. To that end, Allergan is working in full collaboration with the FDA, the Centers for Disease Control and the Federal Bureau of Investigation to combat counterfeiting so when patients ask for our products, they can be assured they are receiving authentic Allergan treatments that have been properly tested and deemed safe for use.
Additionally, there have been high-profile cases of arrests made of doctors who were providing their patients unlicensed and unapproved products and misrepresenting them as our Allergan products. The marketing and use of unlicensed and unapproved botulinum toxin is both dangerous and unlawful and we will continue to work closely with the appropriate authorities to prevent this practice from occurring in the future.
Drug Importation and Re-importation
The issues of drug importation and drug re-importation also pose a danger to the quality of pharmaceutical products. In the United States, drug importation is a major public policy issue. Price controls in countries like Canada keep prices of prescription medicines below U.S. market prices, and there have been proposals to allow Americans to buy safe and effective drugs from other countries. We believe legalizing prescription drug importation is a highly dangerous way to help people better afford their medicines and it is our position that laws prohibiting the importation of prescription drugs into the United States are necessary to protect the health and safety of American consumers.
Corporate Statement on Animal Testing
The U.S. Food and Drug Administration (FDA) and other worldwide health regulatory agencies currently require all pharmaceutical and medical device manufacturers to protect patients and consumers by establishing product quality, safety and effectiveness through approved and validated testing methods, which may include animal testing.
When animal work is necessary, it is designed to ensure the highest standards of animal welfare and undergoes ethical review, approval and oversight from an Institutional Animal Care and Use Committee (IACUC).
Allergan shares the pharmaceutical industry's goal of reducing or eliminating animal testing wherever possible and is committed to the "3Rs" principles of refinement, reduction and eventual replacement of laboratory animals in product testing. In this regard, Allergan has developed and gained regulatory approvals of a cell-based potency assay to replace an animal-based assay for use in the ongoing manufacturing of BOTOX®. Allergan uses only the cell-based potency assay when performing BOTOX® drug product release and stability testing.
For additional information or questions, please contact Allergan Customer Relations:
Phone: 1 (800) 678-1605