Category Archives : Regulatory


FDA releases draft guidance on off-label communications.

The U.S. Food and Drug Administration has issued the highly anticipated draft guidance to drug makers on how they may communicate with physicians about off-label use of products. The guidance offers a number of ways that manufacturers can share truthful and non-misleading information-and still meet the FDA’s definition of being consistent with a brand’s FDA approved labeling. Examples include:             How a product performs in specific sub-groups within it’s approved patient population             Data about long term safety and efficacy of products treating a chronic condition             Updates from head to head trials with drugs for the same indication and […]


Summary: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

In summary, I presented seven relevant cases and some key learnings for promotional guidance. In a new class, the mechanism of action needs to be pulled through to show that it actually made a difference in the clinical trial results. In the pharmacokinetics, we saw that a difference on label of PK performance could have promotionally relevant and competitively viable differences in dosing. In drug delivery and release, we saw that the profile of the therapeutic window could be promotional, allowed, if it were also shown to be patient-relevant in either efficacy or side effects. When we looked at dermatological […]


Case 7 “Ingredient Performance”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now the seventh area is ingredient performance. The brand example here is a PICC line or a peripherally inserted central catheter that was in development by a major medical device company. This central catheter was made from a novel plastic compound as well as an anticoagulant coating that actually prevented clots in the patient. They had some very dramatic photographs showing side-by-side results of other catheters and the clots that actually formed around them versus this catheter that was made of the novel plastic and coating that did not have any of the blood clots. However, when it came time […]


Case 6 “Surrogate Markers”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now let’s take a look at the sixth case, surrogate cardiovascular markers. The brand examples I share here are Advicor, which was a combination statin and niacin for the reduction of cholesterol and other related lipid components. In addition, Enkaid was a class 1-C antiarrhythmic. Now, in the case of both Advicor and Enkaid, we were able to promote that they reduced surrogate markers of cardiovascular disease, but not necessarily reducing the end results of those diseases. Let me explain. Advicor could be shown to reduce total cholesterol, reduce triglycerides, and reduce LDL cholesterol, as well as increasing the HDL. […]


Case 5 “Potency”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The fifth case is an antibiotic potency. Now, over my career, I’ve been able to work on three particular oral antibiotics, Augmentin, Biaxin, and Cipro, all in slightly different classes of antibiotics, but all with a similar kind of message or claim, and that is the broad spectrum coverage of a lot of bacteria and less resistance to those potentially affected bugs. Now the regulatory lesson here is that the idea of spectrum coverage always had to have a footnote that in-vitro activity did not necessarily imply in-vivo efficacy. In English, that meant that just because in a petri dish […]


Case 4 “Efficacy”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The fourth case is in the area of efficacy, specifically dermatological efficacy. I think this has always been fascinating to me. That’s why I wanted to share a range of over-the-counter brands like Keri Lotion and PreSun, a high SPF sunscreen product, as well as prescription brands, particularly Lac-Hydrin and Botox, a well-known injectable product. Now the key claim for these products range from simply treating dry skin to aging skin. There was actually a big difference between showing the signs and symptoms of dry skin to PreSun, which was, because of the sunscreen component, could actually claim to prevent […]


Case 3 “Drug Delivery & Release”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Let’s take a look at the next case. Number three is drug delivery or a different kind of drug release. The brand examples here are Vivaglobin, an IVIg product, and the octreotide implant that was a growth hormone inhibitor product in development at a major pharma company. The key claim for both of these is that there would be no more roller coaster of drug effects, either over delivery of the drug, which would cause untoward side effects, or, along the way, a roller coaster down of loss of effect and even under-protection because the product went below the therapeutic […]


Case 2 “PK”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Let’s take a look at the second case. This is in pharmacokinetics. A particular brand example was Daypro, a non-steroidal anti-inflammatory drug. The key claim for Daypro was that it could provide day-long confidence and proactive control – a tagline that was created to reflect its brand name. This was based on a PK profile that there was no drug accumulation with chronic dosing. The kidneys could be spared drug accumulation even if the patient took it once a day, every day — instead of just as needed for pain. This became a real promotional and competitive difference for Daypro, […]


Case 1 “New Class”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The first is new class. The brand examples are from my experience with Cozaar & Hyzaar, these are A-II receptor blockers for hypertension. The other is Celebrex. It was the first COX-2 inhibitor for arthritis. The key claim in both of these was that they were first in a new class of treatments for their respective diseases. They were effective without causing a specific and well-understood side effect in the class. In the case of Cozaar and Hyzaar, there was a reduced incidence of ACE inhibitor cough. In the case of Celebrex, there was greatly reduced NSAID gastrointestinal problem. Cozaar […]


Introduction to “Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion”

This week, I presented views on “Navigating Regulatory Expectations” from my role as a brand innovator. The first part I shared was the basis for commercialization strategies that I’ve seen pharma and medical device companies use. Then I shared lessons learned from seven relevant cases. I’ve chosen this illustration of an Idaho river and some rafters to illustrate the idea of navigating regulatory guidelines, because I believe that there are ups and downs and there are some calm waters and there are some choppy, white waters all through the process. If you learn to navigate them then you can have […]