Dear Consumer:
I know I addressed this letter "Dear
Consumer" but really I know you better than you think. You're a mom, a sister, a friend. A father, a husband, a son. You have a name. You might be someone that was just diagnosed, and you're seeking answers. You might be long-suffering from a chronic, debilitating disease, and you're seeking relief. Based on discussions with your doctor, you're hoping I can help you. What you may not know is, I'm really hoping I can help you, too.
My name is Pharma. And I'm not as bad as you think.
You might have been looking for information online recently. Let me guess ... Google, Yahoo, Bing? PatientsLikeMe.com? Online communities specific to your condition? You might even be searching and discussing on Facebook and Twitter. You're reading and connecting and looking for help, hope, and support wherever you can get it.
And I (Pharma) am noticeably absent.
I am sorry I can't talk to you. I really, really want to. But my hands are somewhat tied right now, my voice muffled. And I know you probably don't understand why. So here's my attempt at an explanation that I am hoping will help:
- You probably already know that the FDA heavily regulates how pharmaceutical companies communicate with consumers if it can in any way be considered promotional or advertising in nature.
- They do this for a reason - to help ensure your safety.
- They want you to understand that there are risks associated with every drug. They want to make sure those risks are as up-front and obvious as all of the positive things we have to say about our drugs (hence all those side effects being mentioned in the TV ads you see).
- FDA also wants to make sure that we (Pharma) talk about our drugs only in the context in which FDA approved them, or "on-label." For example, if a drug was approved by FDA to treat asthma but it is sometimes prescribed by a physician for COPD or another related illness, we just can't talk about that with you. That would be considered "off-label" promotion. Your doctor is the best person to discuss that with.
- Also, FDA requires Pharma to report to FDA any drug side effects or "adverse events" from consumers. This is so that if there are any problems that arise with the drug, they want to be able to identify those problems early and address them quickly.
- While the FDA has provided fairly clear guidelines on how pharmaceutical companies should address these three things -- balance of risks/benefits, on/off-label promotion, and side effect reporting -- when it comes to traditional advertising, the FDA has never told Pharma how they should use the Internet and social media to advertise. The only thing FDA has done is tell Pharma when it did something wrong.
So, it's not that the FDA says I
cannot use the Internet or social media to communicate with you. They've just never been very clear on exactly
HOW I can use these mediums without crossing the imaginary line. And by not providing clear guidance, it makes our lawyers and the other people responsible in our organizations very nervous. They don't know what the rules are, so they can't judge whether the communicators are following them or not. And if we break the rules, there can be pretty severe consequences in the forms of warning letters, steep fines, required corrective action, and other reprimands. So you can probably understand we don't like to risk it.
I know I've made mistakes in the past. I know you don't trust me. And I know staying silent certainly doesn't help.
In fact, I don't blame you for mistrusting me. I'm not communicative. I'm not transparent. I interrupt your 10:00 news with silly animated TV commercials featuring details of disgusting side effects. You search for information online but there's only so much I can say. You might even end up on my Web site and look for a place to ask a question, to submit a complaint, but there is none.
I hope things will change. I'm trying. With the upcoming
FDA hearings, I am hoping not just to get direction on how to "advertise" to you on the Internet and within social media. I want to talk to you. Have a conversation. Get to know you. See what you need; see how I can help. To provide support ... when and where you need it. (And I'm interested to know ... do you even
want to have a conversation with me?)
At the end of the day, I'm Pharma, but I'm a person too. I'm a mom, a sister, a friend. A father, a husband, a son.
Someday, perhaps, we'll be able to chat.
Sincerely,
Pharma
I finally got a chance to post my slides for the FDA hearing here.
