Working in Pharmaceuticals and Medical Devices
It’s important anyone working in this industry understands the restrictions on what pharma and med device companies can do. Focus on what is best for the patient and how restrictions protect them, and you’ll do great.
There are challenges when working in any industry that is regulated by the FDA. Much of that is the industry’s own doing. There is a long history of suspect business practices that weren’t in the best interests of the patients who benefitted from their products. Just watch one of the many documentaries on the business practices that have created the opioid epidemic.
On the flipside of that argument, life expectancy has dramatically increased over the years because of advances in life sciences, much of which are the medications that keep us alive today. So working in Pharma and med devices can be rewarding. You’re helping patients. It is very challenging to do this well, but it’s very rewarding if you do.
People working in Pharma and Medical Devices are beholden to several areas of oversight:
FDA - the Food and Drug Administration
PHRMA - a professional organization overseeing the pharma industry
AdvaMed - a professional organization overseeing medical technology
Liability issues - a company protecting itself from lawsuits
Medical - a company ensuring they are providing medically-accurate information
HIPAA - laws protecting peoples’ privacy of their Health Information
Healthcare Professionals (HCPs)
The bulk of promotional activity is spent on the professionals who are involved in the healthcare decisions of health consumers rather than the consumers themselves. We use the acronym HCPs to refer to Healthcare Professionals. They can be physicians, nurses, pharmacists, therapists and anyone else with the authority to make medical recommendations for patients.
The vast majority of HCPs are not swayed by material things when it comes to the welfare of their patients. But, history has shown that enough of them have been influenced by gifts, money, junkets, etc. that they should be concerned. These days there are a lot of restrictions on what the industry can offer to HCPs while promoting their products.
Medical/Legal/Regulatory Reviews
Before we get into the details, it’s important to know that anything that can be seen by the public (ads, websites, sales materials, documents, etc.) must go through a review by a panel of experts. So whatever you create will be reviewed at the very least by someone with a medical degree, a lawyer, and someone with expertise in government regulations. Companies have different names for this group of people - copy committee, PRC, etc.
I once designed a website for a product that had a thing we called a “Black Box Warning.” Medications that have the highest concerns for safety have these warnings. At the time, the warning was surrounded by a black box, hence the name. The FDA had recently issued new guidance around box warnings that caused a stir. Buried in the guidance, I learned that a certain document required the warning to be a very specific typeface, size, and shade of red and surrounded by a red box. When the committee reviewed my work, they flagged my use of red. I referred them to the FDA guidance. They were flabbergasted, “Why is it called a black box warning when it has to be red?” We ended up sharing our PDF document with all of the other teams about to launch their materials. A crisis was averted. This happened because I read the guidance when nobody else did.
Med/Legal/Reg review panels may say “no” a lot or offer suggestions on how to fix their issues. They often default to telling you what to do without context. They do this because they have a lot to do, not because they want to be opaque. If they have not told you why, you should ask. “Help me understand what concerns you so I can fix the issue.”
Treat review committees as the experts that they are. While they’re being critical of your work, keep in mind this is what they do all day long and it’s not fun.
Being on these committees is a very risky job. It will end their career if they sign off on something that results in a fine or a drug being pulled off of the market.
The Label
In pharma, you will hear a lot of talk about “the label” when referring to a product. The label is the Prescribing Information or Package Insert, simplified as “PI”. The PI outlines everything the product is approved for, the conditions under which patients should be treated, and the risks of treatment. The product can ONLY be marketed for what is in the PI. Any violations will result in massive fines and/or the drug being pulled from the market.
This is why you see a lot of very vague advertising and packaging for medications. If your allergy drug’s commercial shows happy people enjoying a picnic and doesn’t mention hay fever, it’s safer.
Promotional Materials
Anything produced to sell a product is referred to as “promotional.” TV ads, websites, banner ads, PDFs and printouts shared with HCPs and patients, slide decks, etc. This also covers what representatives of a company say about a product to the public.
If you work for a pharmaceutical company and your mom asks you, “If I take this drug, will I lose weight?” and it’s not an approved use for the drug, saying “Yes” is breaking the rules.
All of these materials must cover only what the drug is approved to treat by the FDA, and they must list the risks of that product alongside the benefits.
Fair Balance and Equal Prominence
Terms like “fair balance” and “equal prominence” are as far as the guidance gets. It’s up to the company to make a judgment call on whether they are being fair and equal, then wait for the repercussions. That’s why many Med/Legal/Regulatory reviewers are so conservative.
When a product is marketed, there must be “fair balance” between the benefits and risks of those treatments. The risks must be presented with “equal prominence” as the benefits.
Equal prominence is intentionally vague, so different companies have their own interpretation. Generally it means that risk statements cannot be buried or obscured when compared to a benefit statement. You shouldn’t have a 120-point banner on a print ad that says the product cures ear hair, then an 8-point disclaimer on the bottom of the page that says it causes your teeth to fall out.
Medical Information and Scientific Exchange
Companies segregate their Scientific Affairs groups from their Promotional groups, often going to the length of having two separate legal entities under a parent corporation.
Medical Information is a technical term that refers to non-promotional materials. This is information specifically requested by HCPs to help them do their jobs. It must be unsolicited and the response must be from scientists, not marketers or sales people. How does this happen and what does it mean?
Say you are a doctor and you have a patient who has been taking maintenance medication for a chronic disease for the past six years. At her next appointment, she says, “I just learned I’m pregnant, should I keep taking this medication?” You may not know the answer. Clinical trials are rarely conducted on pregnant people. When clinical trial participants become pregnant, they remove them from the trial, stop the treatment, and monitor the pregnancy and the health of the baby after the birth. As a physician, you need that data right away. Because the label says not to prescribe it during pregnancy, your sales representative cannot answer those questions. They’ll refer you to Scientific Affairs. HCPs can interact with Scientific Affairs in a few ways:
Calling a call center staffed with people who have scientific/medical backgrounds
Asking for someone with a scientific/medical background to visit them live or virtually
Reviewing a website with medical information that is built under very specific standards
All of these resources are built very carefully so they are not promoting the product in any way. They present data without opinions to help HCPs make informed medical decisions.
Adverse Events and Product Quality Complaints
The industry term for side effects is “adverse event.” An adverse event covers anything negative that may happen while using a product. Since there is no way to immediately determine if that event is related to the product, companies have to be very careful about tracking adverse events when they are made aware of them.
If a pharma sales rep is meeting with a doctor to talk about a new drug and that doctor says, “Funny story. My patient was taking your other drug and all his hair fell out.” then the sales rep has to let the doctor know that is a potential adverse event and inform people in the company who will investigate.
If you think about it, this is very important. If a product causes a terrible reaction to a small population of people, it may not have been caught in a clinical trial. So the company has to monitor their product the entire time they are selling it to ensure the safety of their patients Interestingly, pregnancy is considered an adverse event because some medications have been known to counteract the effectiveness of birth control. It is very important for HCPs and patients to know that.
Whenever anyone representing a company learns of an adverse event, they must report it. Whether you’re an accountant or a freelancer at a pharma company, if your neighbor says, “Every time I take your medicine, I get a headache” you need to report it, usually within 48 hours or so.
Conducting Market and User Research
Researchers go through training to be certified to conduct research at a company and all of the materials they create to share with their research participants have to be reviewed by a committee. Because of concerns about influencing HCPs and consumers when promoting a product, people conducting research have to be very careful.
Researchers must avoid promoting products - research is for information gathering not promotion.
Researchers must monitor participant feedback for adverse events and product quality complaints.
Researchers can compensate participants for their time and feedback, but it must follow industry standards.