“Failing to plan is planning to fail” says time management guru Alan Lakein. Nowhere does this axiom ring more true than in the tightly controlled world of Rx launches. Given the time and expense required to bring a prescription drug to market, coupled with its limited exclusive lifespan, we must maximize every moment from market conditioning to loss of exclusivity (LOE). Commercial teams can take steps before, during and after a new product’s approval to ensure that its launch – arguably the single most important event in a brand’s lifecycle – propels it to its full promotional and commercial potential. Here we explore five ways to create the conditions for category leading success, keeping both compliance and marketing effectiveness in mind:
- Compliant digital planning for education, pre-launch, launch and full promotion phases
- Building and engaging a pre-launch audience to maximize brand reach and impact
- Creating an effective day-of-approval (DOA) website and synchronized search campaign
- Preparing your fully researched search engine marketing (SEM) campaigns and expertly staging them
- Fully utilizing owned brand and manufacturer’s social presences to connect effectively with key audiences
Ground Rules for Pre- and Post-Launch Promotion
The Food and Drug Administration (FDA) prohibits promoting prescription drugs prior to approval. Previous direction about pre-approval promotion set forth two types of compliant communications:
- “Institutional” promotion – advertising that a “specifically named drug company is conducting research in a certain therapeutic area” – such language can broadly elaborate on the nature of research, i.e. “developing a new treatment” or “researching a new mechanism of action (MOA)”, without mentioning any drug by name, OR
- “Coming Soon” promotion – announces the name of the drug but does not “make written verbal or graphic representations or suggestions concerning the safety, efficacy, or intended use of the product.”
It’s important to note that a brand must choose one of these product-oriented alternatives. As soon as one happens, the other option is off the table until the drug is approved. However, disease state education (DSE) marketing that does not address product or its attributes, MOA, etc., can in fact be run in addition to either “institutional” or “coming soon” advertising under the right circumstances. While this direction was issued in 1994 and technically withdrawn in 1997 when FDA adopted its Good Guidance Procedures, subsequent actions from the Agency continued to refer to this as if it were still the official FDA position, so it is generally accepted as such by the industry.
Immediately upon approval, much of what it takes to make the most out of a launch revolves around effective and comprehensive management of the 2253 filing requirement. All advertising and labeling of a prescription drug must be submitted to the FDA at the time of initial dissemination or prior to use under cover of Form 2253 and accompanied by the approved product label. Because there is no approved product label until the drug is approved, brands must synchronize the submission of any associated promotional information accordingly. Companies can fulfill their 2253 filing requirement by submitting their promotional materials to the FDA at the same time that they begin using them; so appropriate planning and review of these communications prior to approval is crucial to maximize the marketing benefits of any Rx launch.
Pre-launch Audience Development
There are two incredibly valuable professional audience categories that can be amassed and teed up for activation prior to launch, while adhering to the regulations:
- Potential prescribers – specialists who diagnose, treat, and prescribe medication to patients with the disease.
- Brand curious – potential prescribers who have already learned of the product in development
Both audiences can be engaged in a communications funnel that lays the groundwork by establishing both baseline awareness and a “reason to believe”. Well-prepared brands with a competitive battle plan can gain an outsized advantage by first preparing the market with educational content that establishes the importance of the problem the product solves and makes it top of mind in terms of advancing the quality of future care. From a digital media perspective, the benefits extend further still – a disease awareness initiative opens an otherwise closed door to paid search ads that target healthcare professionals and patients actively seeking disease and related scientific, diagnostic, treatment, and safety information. Further, the ad copy and corresponding landing pages on an unbranded disease awareness site can go deep into important considerations about the scientific and biological underpinnings that HCPs need to be thinking about to value the importance of the upcoming product, once it is launched.
The marketing benefits to brands are manifold – to name a few:
- Using “pull” messaging to acquire qualified pre-launch professional and consumer audience databases for subsequent email, social and programmatic communications allows brands to later achieve immediate awareness with deep reach via “push” messaging at launch
- A well-conceived market conditioning campaign serves as a living laboratory of marketing insights compiled pre-launch with respect to channel, messaging and content preferences of core segments, minimizing the need to use up valuable time in market “testing in” to digital marketing strategies.
- Coming full circle, the disease education in market ensures that, upon launch the desired target will already be better informed with the information tools needed to be “conversion ready” – receptive to the new product’s unique MOA and efficacy story.
As word spreads to interested brand targets about a new product, the most common reaction will be reach for the nearest device (laptop, mobile phone, tablet, etc.) and type “PRODUCTNAME” or “PRODUCTNAME.com” into the browser. This serves as the brand’s opportunity to have the “first word” by making sure a “coming soon” or “now approved” abbreviated website is in place at the earliest possible time.
Such queries will without doubt occur prior to the product’s release into the market and, while volume may be low, the value of engaging these early “brand curious” professional targets is disproportionately high. Given a direct relationship, a reason to believe and key points addressing potential obstacles to prescribing, many of these receptive specialists have the potential to become top-decile prescribers. Using the right combination of “disease state education” and either “coming soon” or “institutional” product oriented communications, the brand and its media/analytics partner should align early on to understand how target segments engage, even before launch. Such intelligence is invaluable in shaping both personal and non-personal promotional strategy.
On the day of approval, it is important to consider that even as the drug is made available in pharmacies, no physician will yet have written a prescription – and even as the first prescriptions are written, no insurance company will yet have agreed to cover the cost of the drug on its formulary. Consequently, even before driving patient/doctor discussion, the goal for a commercial team as of the day of approval should continue to be collecting names and contact information for the people who were interested in learning more, so that as key obstacles to the drug’s accessibility are overcome (such as availability in pharmacies and formulary coverage), they can be alerted. The media landscape has evolved to the point that such databases can be leveraged far beyond direct mail and email communications – with the appropriate disclosures and opt-ins, social media channels and list-derived programmatic platforms can exponentially increase the reach and impact of such exposure at launch.
Of course, the registration process should make it clear that people are accepting the receipt of future marketing messages both online and offline. These terms must comply with all appropriate data collection procedures and CAN SPAM provisions, in addition to FDA regulations. Also, remember that people from a variety of perspectives will want to register for updates (doctors, pharmacists, potential patients, caregivers, and others). During the registration process, people should be able to self-identify (possibly in more than one category) so that they can receive the most relevant follow-up communications.
Day of Approval – Breaking News and Building Relationships
The purpose of a day of approval (DOA) site is to affirm that the product is approved and to collect contact information from people who are interested in learning more as updates are available. In this sense, a DOA site is the rare instance in which you as a pharma marketer are literally breaking news – in fact, you become arguably the most authoritative source on the web for the story – living proof of the drug’s approval. As such, the single most important marketing consideration for a DOA site is to ensure it launches immediately upon receipt of approval by the FDA. Any complication to the design or content of a DOA site that might delay its timely launch should therefore be avoided. Also remember the site has to simultaneously be submitted to FDA to meet the 2253 filing requirement.
The ideal DOA site has the following features:
- Brand logo
- Link to the current prescribing information
- Link to the press release (if any) announcing the drug’s approval
- Link to the FDA announcement (if any) about the drug’s approval
- Link to the Risk Evaluation and Mitigation Strategy (if any) for the product
- Ability to register for updates
Anything further introduces dangerous complications – depending on the exact contents of the final label, last-minute updates could delay the ability to launch, resulting in crucial missed opportunities to introduce the brand and register interested users for future communications.
Keep in mind that a significant share of traffic will come from mobile devices, so a mobile friendly DOA site is vital, especially if you want to use mobile advertising to generate ad revenue. Despite the brevity of its existence, the DOA website has a unique immediacy of purpose for the audience as well as the brand. If it is not imminently discoverable by mobile search or easily viewed on a mobile device, far more mobile searchers will simply scroll down the search results to find sites providing the information needed rather than waiting until their next desktop session to start over again.
Paid Search – Prepare Well in Advance and Launch Immediately
A well-orchestrated cascade of pre-launch, coming soon, day of approval and full promotional websites requires an equally thoughtful and spotlessly executed paid search effort. Paid search campaigns must be strategically aligned with digital strategy and content development from the earliest concept review, and the review, approval and rollout of assets must be fully integrated and synchronized.
Every brand hopes that users will find its website listed at the top of organic search results. But for a brand new site with limited content that the engines have not had time to index, there is little to assure marketers that they will rank on the first page – let alone in the first position – making paid search critical for a successful DOA launch. With or without top organic rankings, relevant keyword searchers should also be served a well-crafted paid ad directing them to the site, visible on any device, and from all of the top search engines. The presence of a sponsored link served in conjunction with an organic listing invariably drives significantly more traffic, typically at low cost due to the limited number of advertisers bidding on a brand term. This also ensures that more first page results lead directly to your DOA site, where you can collect user information and otherwise identify visitors to contact or retarget with updates as available.
Optimize PR for Search and Fully Engage Social Media Presences
Increasingly, we consume news through social media and this is no less true for healthcare professionals, who subscribe to the feeds of authoritative medical journals, healthcare providers, and other influencers. Consequently, brands should leverage every appropriate “owned” social presence (whether corporate, brand or division) to share news of the approval. Some announcements will qualify as product promotion and be subject to the 2253 filing requirement discussed earlier, but social media should be fully tapped to make the most of the brand’s moment in the limelight. Further, every announcement on such platforms should include a call-to-action, either to click through to the DOA site or to engage with an approved version or subset of that experience natively. In either case, users can be prompted to register for updates or engaged with high-value assets.
Importantly, given the limitations on branded content prior to and on the day of approval, press releases, social posts, and related coverage provide a huge assist in filling the gap in available information. These items can directly support the DOA site and can be a secret weapon when marketing and communications are aligned. And don’t forget to make sure your search engine optimization (SEO) team weighs in on press release structure, language, use of inbound links, and cross-channel distribution opportunities. Just as with the other DOA opportunities, most of this work should be done well in advance of the day of approval itself.
“Failing to plan” is rarely more damaging than in the case of a new drug launch. It’s vital to make the most of every major milestone in a brand’s lifecycle, and the most important of these milestones is its FDA approval. With an appropriate plan in place, brands can use well-conceived digital content and tightly integrated search/digital media to fully utilize the digital channels we use in our daily lives, while simultaneously developing their audience and gaining key pre-launch insights, providing every possible advantage for category leading success once in market.
(1) “Current Issues and Procedures (FDA Letter to Industry),” April 1994 available at http://prod-admin1.tmg.atex.cniweb.net:8080/preview/www/2.3427/2.3628/2.5317/2.11873/1.82998?ot=tmg.PrintPageLayout.ot&print=1
(2) Federal Register, Good Guidance Procedure Announcement, 1997.
(3) MACMIS #6643: Letter to Merck & Company for promotional materials for Aggrastat(tirofiban hydrochloride) Injection, issued 11 May 1998, available at FDA website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168207.pdf. Accessed 1 December 2016.
(4) 21 CFR 314.81(b)(3)(i) and 21 CFR 601.12(f)(4)