Medical Affairs
BioPharm companies that have products on the market, or coming to market, usually have a Department of Medical Affairs. Medical Affairs staff enhance communications with physicians, pharmacists and consumers and help separate the exchange of medical information from commercial activities. Physicians, PharmDs, and PhDs fill many important roles in Medical Affairs.
Medical Affairs Departments may include one or more of the following services;
Medical Information, a group that provides information about the company’s
products to consumers and prescribers;
Medical Writing, a group to prepare educational materials or help with
publications;
Medical Science Liaisons (MSLs), a group of physicians, pharmacists or other
scientists who interact with key physicians or Investigators;
Safety, a group responsible for reporting postmarketing adverse drug reactions;
Clinical Research, a team of medical monitors, CRAs, data managers and
Biostatisticians who conduct Phase IV or line extension studies and
Patient Support, a team focused on consumer education and/or access to and
financial assistance for the company’s products.
Some companies are too small to have separate departments for each of these activities and they may depend upon their Research staff for assistance. Some companies outsource some of the activities to outside consultants or contract organizations. One way or another, the important work of Medical Affairs gets done.
Let's look a bit more at some of these activities.
Medical Information
Physicians and PharmDs play important roles in Medical Affairs. They may be Department heads or individual contributors.
Why do companies need Departments of Medical Affairs? BioPharm companies can only “promote” their products for the indication(s) approved by the FDA. This means that the information in journal ads, on websites, or discussed in company-initiated physician visits is limited to material found in the product Prescribing Information (PI), sometimes supplemented peer-reviewed summaries about the pivotal studies. But physicians often want to know more about the drug or device. The FDA regulates the approval and marketing of medical products but the FDA does not regulate the practice of medicine. Doctors can use drugs or other products in any way that might be beneficial to their patients.
Sales and marketing staff cannot answer questions about unapproved "off-label" use but Medical Departments can. Current regulations allow companies to answer "unsolicited" questions any about unapproved use as long as the responses are truthful, balanced, non-promotional, and responsive to the specific request. The term “unsolicited”, means that the company cannot encourage the physician to ask the questions. In most companies, staff from Medical Affairs are responsible for these interactions.
For example, let’s assume a product is approved for treatment of kidney rejection and a doctor asks if the product could be used for liver transplants, too. A sales representative would have to refer that question to Medical Affairs. The Medical Affairs staff would first remind the doctor that the product was not “approved” for hepatic rejection, only for kidney rejection and offer to provide the approved PI. But then, he could discuss the safety and efficacy results from any studies conducted by the company or others for hepatic rejection. If there were both positive and negative studies, he would have to give all of the information. But the Med Affairs representative could not discuss studies in heart transplant unless the doctor asked specifically about heart transplants or unless there was some important safety information to convey. The Medical Affairs department would need to record of this interaction to show that a balanced response had been given, that approved Prescribing Information had been offered, and to show that the company was not soliciting physicians to ask about liver transplants; only responding to legitimate requests. We have provided a link to the FDA Draft Guidance called Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices in the Guidance page in Resources. If you are interested in Medical Affairs, I would encourage you to read this Guidance.
Medical Safety Liaisons (MSLs)
There is a growing opportunity for doctors in the role of Medical Safety Liaisons (MSLs), sometimes call Scientific Advisors. MSLs are usually physicians, PharmDs, or PhDs, with specialized training in therapeutic fields of interest to the company. MSLs are usually part of Medical Affairs Departments. MSLs often call upon academic physicians, the so called “Key Opinion Leaders” (KOLs), and physicians or pharmacy groups. They provide in-depth scientific information at medical meetings. They serve as peers to the prescribing community and scientific experts within the company. If you go to our Resource page, you will find a link to the Medical Science Liaison Society, a non-profit organization dedicated to advancing what they call “the global MSL career”. The MSLS website provides some the history and a concise description of the role of MSLs today, a link to educational resources and career links.
Clinical Research
Medical Affairs departments may also have their own Clinical Research groups including medical monitors, CRAs, biostatisticians, and data management staff. Physicians, PharmDs, and PhDs all play roles as team leaders or medical monitors. These doctors develop protocols, help plan data collection and study analysis, recruit researchers and supervise the conduct of the study, usually with a team of CRAs. They may also be responsible for reporting the results and presenting abstracts at meetings. Physicians in Clinical Research may also assist academic investigators with investigator-sponsored studies. These Clinical Research groups follow the same GCP regulations as other Clinical Development groups but they can help prioritize Phase 4 or line extension studies of interest to the commercial group.
Postmarketing Safety and Pharmacovigilance
Physicians also play important roles in Safety Departments, again as Department Heads or monitors. In clinical trials, adverse events are actively solicited; at every study visit patients are asked whether or not they have had any adverse events. The investigator assesses whether or not the event is related to the study drug or device and determines whether the event is Serious. After a product is marketed things are a bit different. If a physician, pharmacist, patient or a family member calls to report a problem with a drug or device the assumption is that they must think the adverse event is drug or device-related. Each of these events must be reported as Adverse Drug Reactions (ADRs). In addition, a lack of effect, i.e. “a failure of the drug to produce the expected pharmacologic action”, is also considered to be an adverse experience with a marketed drug and must be reported. So, if a patient calls to ask for a refund because his/her pain medication did not help, that is an adverse experience and must be reported. For more details about postmarketing safety reporting, we have included links to two FDA Guidance Document the Guidance tab in the Resource section.
An example of the role of a physician in Medical Affairs
My first role in industry was in Medical Affairs, in a Department called Medical Services. Our Medical Services group included Medical Information, Medical Writing, and Safety Reporting. Our company had about 20 marketed products and 5-6 more drugs in development; I was assigned responsibility for several of these drugs.
I worked with the pharmacists in the Medical Information group to respond to "queries" about our products from prescribers, pharmacists, and patients. Back then, our questions came by mail, phone, or from the Sales representatives. Today, queries also come via e-mail, social-media. All of our responses included a PI for the approved indication for the drug and references from the literature or in-house materials (“information on file”) to support our responses.
I worked with the Medical Writing groups to prepare educational materials for my products; materials like slide sets, drug monographs, etc. I also reviewed the work of the writers who prepared Clinical Study Reports.
We had a Safety group that handled reports of postmarketing adverse drug reactions. I reviewed the information, contacted the reporting physicians if necessary to get additional details, and worked with the Corporate Safety group to submit reports to the FDA.
I loved the job. It had it’s own share of headaches, some major, some trivial, but it was exciting and the job forced me to go relearn basic information from my medical training that I had almost forgotten. What is the formula to estimate renal clearance? How do oral contraceptives work? And to review key anatomy, physiology, gynecology, virology, analgesia, etc.
One of my other responsibilities was to approve the medical information in any ad for my drugs. Other people reviewed the legal and regulatory components of the ad. One of my assigned products was an NSAID analgesic used for sports injuries. I was asked to approve an illustration of a sprained ankle for an ad in an important orthopedic journal. The medical illustrator had drawn a swollen ankle, with an “incision” that depicted an internal view of the torn ligaments. I had cared for many patients with sprained ankles, but never pictured the pathology so graphically. Nevertheless, It was my job to make sure that the anatomy was correct. I went to Gray’s Anatomy and Grant’s Atlas to refresh my memory of the bones, ligaments and tendons of the foot. The anatomy books showed AP and lateral views of the ankle, but the medical illustrator had gone one step further. She had chosen a unique view, from overhead, just as the foot would look if the ligaments and tendons had been exposed at surgery-- a view that did not match my reference books. So, I spent several hours trying to decide if the drawing was OK. I did not want to be flooded with complaints from orthopedic surgeons telling us that we had gotten it wrong! I finally approved the ad and sent it to the printers. Fortunately, the medical illustrator had done a great job and we had no complaints.
The Future of Medical Affairs
Recently, in a case involving Amarin Pharma, Inc., the Federal District Court in Manhattan that found that the First Amendment protects drug companies that want to make truthful statements about their drugs, even if the statements are about an unapproved use. If this case is upheld or if a higher court agrees, it might mean lead to a modification of the regulations on discussion of off-label use. We will provide a link to a discussion of this case in the Resource Section.
The responsibilities of Medical Affairs will probably expand and evolve and a job in Medical Affairs will continue to be an exciting role for BioPharm doctors. It takes a unique skill set to fill these jobs. In 2012, the consulting group, McKinsey & Company,
summarized their vision of Medical Affairs for 2020 and beyond (see link in Resources). In this article, the McKinsey authors described the skills needed by doctors who work in Medical Affairs.
“The bar is high for Medical Affairs talent. They need to collaborate with R&D
colleagues and deeply understand the science that underpins their work; they
must understand the rules and regulations governing the industry almost as well
as their compliance and legal department colleagues; and they should have the
strategic thinking capabilities of their marketing counterparts as well as the
customer-interaction skills of their colleagues in sales.”
It's an exciting career.
BioPharm companies that have products on the market, or coming to market, usually have a Department of Medical Affairs. Medical Affairs staff enhance communications with physicians, pharmacists and consumers and help separate the exchange of medical information from commercial activities. Physicians, PharmDs, and PhDs fill many important roles in Medical Affairs.
Medical Affairs Departments may include one or more of the following services;
Medical Information, a group that provides information about the company’s
products to consumers and prescribers;
Medical Writing, a group to prepare educational materials or help with
publications;
Medical Science Liaisons (MSLs), a group of physicians, pharmacists or other
scientists who interact with key physicians or Investigators;
Safety, a group responsible for reporting postmarketing adverse drug reactions;
Clinical Research, a team of medical monitors, CRAs, data managers and
Biostatisticians who conduct Phase IV or line extension studies and
Patient Support, a team focused on consumer education and/or access to and
financial assistance for the company’s products.
Some companies are too small to have separate departments for each of these activities and they may depend upon their Research staff for assistance. Some companies outsource some of the activities to outside consultants or contract organizations. One way or another, the important work of Medical Affairs gets done.
Let's look a bit more at some of these activities.
Medical Information
Physicians and PharmDs play important roles in Medical Affairs. They may be Department heads or individual contributors.
Why do companies need Departments of Medical Affairs? BioPharm companies can only “promote” their products for the indication(s) approved by the FDA. This means that the information in journal ads, on websites, or discussed in company-initiated physician visits is limited to material found in the product Prescribing Information (PI), sometimes supplemented peer-reviewed summaries about the pivotal studies. But physicians often want to know more about the drug or device. The FDA regulates the approval and marketing of medical products but the FDA does not regulate the practice of medicine. Doctors can use drugs or other products in any way that might be beneficial to their patients.
Sales and marketing staff cannot answer questions about unapproved "off-label" use but Medical Departments can. Current regulations allow companies to answer "unsolicited" questions any about unapproved use as long as the responses are truthful, balanced, non-promotional, and responsive to the specific request. The term “unsolicited”, means that the company cannot encourage the physician to ask the questions. In most companies, staff from Medical Affairs are responsible for these interactions.
For example, let’s assume a product is approved for treatment of kidney rejection and a doctor asks if the product could be used for liver transplants, too. A sales representative would have to refer that question to Medical Affairs. The Medical Affairs staff would first remind the doctor that the product was not “approved” for hepatic rejection, only for kidney rejection and offer to provide the approved PI. But then, he could discuss the safety and efficacy results from any studies conducted by the company or others for hepatic rejection. If there were both positive and negative studies, he would have to give all of the information. But the Med Affairs representative could not discuss studies in heart transplant unless the doctor asked specifically about heart transplants or unless there was some important safety information to convey. The Medical Affairs department would need to record of this interaction to show that a balanced response had been given, that approved Prescribing Information had been offered, and to show that the company was not soliciting physicians to ask about liver transplants; only responding to legitimate requests. We have provided a link to the FDA Draft Guidance called Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices in the Guidance page in Resources. If you are interested in Medical Affairs, I would encourage you to read this Guidance.
Medical Safety Liaisons (MSLs)
There is a growing opportunity for doctors in the role of Medical Safety Liaisons (MSLs), sometimes call Scientific Advisors. MSLs are usually physicians, PharmDs, or PhDs, with specialized training in therapeutic fields of interest to the company. MSLs are usually part of Medical Affairs Departments. MSLs often call upon academic physicians, the so called “Key Opinion Leaders” (KOLs), and physicians or pharmacy groups. They provide in-depth scientific information at medical meetings. They serve as peers to the prescribing community and scientific experts within the company. If you go to our Resource page, you will find a link to the Medical Science Liaison Society, a non-profit organization dedicated to advancing what they call “the global MSL career”. The MSLS website provides some the history and a concise description of the role of MSLs today, a link to educational resources and career links.
Clinical Research
Medical Affairs departments may also have their own Clinical Research groups including medical monitors, CRAs, biostatisticians, and data management staff. Physicians, PharmDs, and PhDs all play roles as team leaders or medical monitors. These doctors develop protocols, help plan data collection and study analysis, recruit researchers and supervise the conduct of the study, usually with a team of CRAs. They may also be responsible for reporting the results and presenting abstracts at meetings. Physicians in Clinical Research may also assist academic investigators with investigator-sponsored studies. These Clinical Research groups follow the same GCP regulations as other Clinical Development groups but they can help prioritize Phase 4 or line extension studies of interest to the commercial group.
Postmarketing Safety and Pharmacovigilance
Physicians also play important roles in Safety Departments, again as Department Heads or monitors. In clinical trials, adverse events are actively solicited; at every study visit patients are asked whether or not they have had any adverse events. The investigator assesses whether or not the event is related to the study drug or device and determines whether the event is Serious. After a product is marketed things are a bit different. If a physician, pharmacist, patient or a family member calls to report a problem with a drug or device the assumption is that they must think the adverse event is drug or device-related. Each of these events must be reported as Adverse Drug Reactions (ADRs). In addition, a lack of effect, i.e. “a failure of the drug to produce the expected pharmacologic action”, is also considered to be an adverse experience with a marketed drug and must be reported. So, if a patient calls to ask for a refund because his/her pain medication did not help, that is an adverse experience and must be reported. For more details about postmarketing safety reporting, we have included links to two FDA Guidance Document the Guidance tab in the Resource section.
An example of the role of a physician in Medical Affairs
My first role in industry was in Medical Affairs, in a Department called Medical Services. Our Medical Services group included Medical Information, Medical Writing, and Safety Reporting. Our company had about 20 marketed products and 5-6 more drugs in development; I was assigned responsibility for several of these drugs.
I worked with the pharmacists in the Medical Information group to respond to "queries" about our products from prescribers, pharmacists, and patients. Back then, our questions came by mail, phone, or from the Sales representatives. Today, queries also come via e-mail, social-media. All of our responses included a PI for the approved indication for the drug and references from the literature or in-house materials (“information on file”) to support our responses.
I worked with the Medical Writing groups to prepare educational materials for my products; materials like slide sets, drug monographs, etc. I also reviewed the work of the writers who prepared Clinical Study Reports.
We had a Safety group that handled reports of postmarketing adverse drug reactions. I reviewed the information, contacted the reporting physicians if necessary to get additional details, and worked with the Corporate Safety group to submit reports to the FDA.
I loved the job. It had it’s own share of headaches, some major, some trivial, but it was exciting and the job forced me to go relearn basic information from my medical training that I had almost forgotten. What is the formula to estimate renal clearance? How do oral contraceptives work? And to review key anatomy, physiology, gynecology, virology, analgesia, etc.
One of my other responsibilities was to approve the medical information in any ad for my drugs. Other people reviewed the legal and regulatory components of the ad. One of my assigned products was an NSAID analgesic used for sports injuries. I was asked to approve an illustration of a sprained ankle for an ad in an important orthopedic journal. The medical illustrator had drawn a swollen ankle, with an “incision” that depicted an internal view of the torn ligaments. I had cared for many patients with sprained ankles, but never pictured the pathology so graphically. Nevertheless, It was my job to make sure that the anatomy was correct. I went to Gray’s Anatomy and Grant’s Atlas to refresh my memory of the bones, ligaments and tendons of the foot. The anatomy books showed AP and lateral views of the ankle, but the medical illustrator had gone one step further. She had chosen a unique view, from overhead, just as the foot would look if the ligaments and tendons had been exposed at surgery-- a view that did not match my reference books. So, I spent several hours trying to decide if the drawing was OK. I did not want to be flooded with complaints from orthopedic surgeons telling us that we had gotten it wrong! I finally approved the ad and sent it to the printers. Fortunately, the medical illustrator had done a great job and we had no complaints.
The Future of Medical Affairs
Recently, in a case involving Amarin Pharma, Inc., the Federal District Court in Manhattan that found that the First Amendment protects drug companies that want to make truthful statements about their drugs, even if the statements are about an unapproved use. If this case is upheld or if a higher court agrees, it might mean lead to a modification of the regulations on discussion of off-label use. We will provide a link to a discussion of this case in the Resource Section.
The responsibilities of Medical Affairs will probably expand and evolve and a job in Medical Affairs will continue to be an exciting role for BioPharm doctors. It takes a unique skill set to fill these jobs. In 2012, the consulting group, McKinsey & Company,
summarized their vision of Medical Affairs for 2020 and beyond (see link in Resources). In this article, the McKinsey authors described the skills needed by doctors who work in Medical Affairs.
“The bar is high for Medical Affairs talent. They need to collaborate with R&D
colleagues and deeply understand the science that underpins their work; they
must understand the rules and regulations governing the industry almost as well
as their compliance and legal department colleagues; and they should have the
strategic thinking capabilities of their marketing counterparts as well as the
customer-interaction skills of their colleagues in sales.”
It's an exciting career.