There were only 3 FDA action letters in 2021, and without that clear guidance it can be much harder to learn how to advance. It is important for organizations to not only understand current enforcement but also the trends in these enforcement actions to gauge FDA’s current thinking.
- Clarify existing FDA requirements for digital assets
- Review FDA enforcement trends in the digital space
- Provide considerations for evaluating digital materials
Telemedicine was an expanding sector with much promise to improve patient access and outcomes even before COVIID - but the regulatory oversightt regime on telemediciine providers is different from that facing biopharma companies. Grasping the changes in regulatory requirements is the first step to improving your outreach.
- Gauge the frequency of off-label promotional messagnig by telehealth companiesClarify existing Contrast the regulattory requirements of the pharma and telehealth sector - and understand where they may intersect with PRC work product
- Antiicipate the likelihood of regulatory change
Maintaining proper balance for new streaming video formats can be surprisingly challenging, as it is governed by older FDA guidances for broadcasts that don’t fully capture the user experience. What elements should regulatory reviewers consider when reviewing streaming media and online video assets?
- Understand the ways “television” has evolved and how the online viewing experience may impact regulatory elements, such as adequate provision of the prescribing information and safety balance
- Envision whether differences across platforms, such as timing limitations, interactivity, and player size will add new areas of risk
- Feel out a common sense application for guidelines that may be decades behind the technologies you are using
On paper it may seem basic to separate communications meant for HCPs, payers, and investors — but between the high focus on CFL and the overall stress the working world has faced during COVID conditions, some companies are still struggling with differentiating between these audiences. Though different types of data are needed for the 3 audience groups, in all cases the standard must remain that communications are truthful and non-misleading.
- Compare and contrast data standards for HCPs, payers, and investors
- Track recent enforcement actions from FDA related to CFL communications
- Learn to respond to colleagues who want to use payer data as clinical data and vice-versa
If properly merged with your asset management format, AI tools can yield more information to your PRC and allow it to complete reviews more quickly. Particularly for label updates, there is a real need, met by an increasing number of vendors, for a tool that will quickly identify and update every location in a promotion where a claim is used.
- Outline the circumstances where an automated tool would be the most useful
- Drive AI uptake through worldwide promotions
- Compare and contrast multiple available services and tools
Some of your colleagues may believe that Investor Materials provided in the public domain can be used carte blanche for other purposes – and that can get you into trouble, not only with OPDP but with DOJ as well. Press releases and forward-looking statements made to investor groups must be reviewed with a different eye, and managed thoughtfully when applied for other purposes such as promotional messages and speaker decks – particularly if your product isn’t approved yet.
- Internalize FDA statements as a deterrent to overeager team members
- Maintain clarity about the different levels of risks facing smaller biotech companies- move this to the first bullet point
- Invite feedback from legal colleagues
Releases to the press may result in a very open forum that lacks the necessary context – and the FDA still sees this, and may take action. Every press release has to be evaluated through a PRC lens to make sure product uses are appropriately communicated.
- Remain cautious and avoid overstating data in any way
- Map out the possible impact of press releases on draft labeling and supplemental NDAs
- Budget in the necessary time for review of media materials
Even though OPDP hasn’t recently provided clear guidance or much public enforcement, you can still sift through past data to gain better insight on their preferences and trigger points. By looking back through letters from earlier years – no matter how rare – you may be able to identify regular themes, anticipate what future enforcement would look like, and help your teams to create impactful and compliant messages.
- Focus on the consistent characteristics and themes of enforcement letters
- Rely on advisory comment to strengthen otherwise unclear enforcement patterns
- Spot the warning signs and construct appropriate responses for of colleagues who want to “roll the dice” that OPDP may remain inactive through a particularly daring campaign
If you learn that OPDP is scrutinizing a particular claim that you have used multiple times, going back and fixing every single use will be highly time-consuming. By building and normalizing the use of a core Claims Compendium, you can allow all cross-disciplinary team members to always point to the right reference and supportive evidence.
- Gather the most important messages from your PI and supportive literature
- Set up your marketing agencies for success in producing materials that aren’t repetitive
- Ensure medical affairs and commercial field teams align on messaging
External stakeholders typically receive communications digitally and not in person, so do you have the best processes for handling modular updates to material rather than wholesale replacements? Best practice for modular submissions to FDA have not yet been determined, which leads to uncertainty among an industry that knows it will have to rely on them sooner or later.
- Prevent the development of an unbalanced appearance in FDA submissions
- Anticipate the needs of digital stakeholders
- Share example of module content submissions of emails and banner ads
Your legal team must be a front-and-center business partner that can advise on any potential speedbumps. Legal partners may be able to bring a big-picture view of the entire organization to the benefit of commercial and marketing colleagues when informing their new tactics.
- Maintain clarity among team members on why changes have happened from a legal perspective
- Stay ahead of notices going to marketing teams
- Acknowledge the differing legal needs of large and small pharma
Given recent FDA guidances on submissions and label broadening, are you using real-world evidence correctly in your promotions – even if it doesn’t go in your label at all? It can be a market advantage to bring real-world evidence into your promotions, but this must prioritize remaining Consistent With Label.
- Understand different applications for Data Consistent With Labels
- Determine proper methods for bringing RWE into promotions
- Gain clarity on Data Consistent with Labels
Celebrity campaigns have been an area of enforcement for FDA, so you must make sure that if an influencer is promoting you on their bespoke channel, they are working within a contract that keeps them informed of how safety disclaimers should look – and keeps you out of trouble. Though they can be very helpful, celebrity activist campaigns are also time-intensive since they often require approval after every round of PRC comments
- Look for an influencer hypertargeted for your audience
- Account for the risks of such high-profile, mass interest communications
- Split off your more aggressive messaging into parallel campaigns that will get less press
If a new company doesn’t have the needed headcount, they can hire vendors for coordinator services – but will still need a back-end connection between operational aspects and the launch readiness team. Do you have the strong link that you need to translate tactical plans and materials into your launch plan?
- Envision the approval workflow for new processes
- Determine how best to get resources through a new system and into reviewer tablets
- Prioritize getting materials through the system without snags
PRC members from different verticals, such as commercial and regulatory, may not have ever worked near each other and instead only came together for meetings. Planning for a launch under these conditions can be highly stressful, and the burden falls not on sponsors or reviewers but on those who run PRC logistical operations.
- Account for changing relationships between sponsors, reviewers, and coordinators
- Take inspiration from successful team-based activities and touchpoints even when members don’t meet in-person
- Acknowledge areas where teamwork has suffered, so you can counteract this
How much authority do coordinators have within your process, and how much backup do they get from leadership? If they are put into a position where it is easier to just push through an imperfect piece and let reviewers “fix” it, the process will take longer, can lead to resentment and reinforce bad behavior.
- Ensure coordinators can recognize problems with references, annotations, and metadata
- Build trust and respect among reviewers/proponents so that urgent, business-critical turnaround may still be accomplished
- Avoid circumstances where incomplete or unacceptable materials cause misalignment between proponent and reviewers late in the process
The recent years of stress and upheaval have hit your team members – hard. Even if they and their families haven’t been directly touched by COVID, concern over bad news and altered working conditions can change their perceptions and ability to fulfill their tasks. PRC managers need to confront this head-on in a sensitive manner while also making sure deadlines don’t slip away.
- Analyze how newly lean operations can put a single reviewer on multiple brands
- Explore methods for keeping team dynamics healthy
PRC colleagues originally from large biopharma companies may be less familiar with behind-the-scenes operations that are now the norm for PRC members. Failing to set the proper expectations puts you at risk of having to write copy during review meetings for pieces that weren’t completely ready.
- Educate team members about the different levels of risk and regulatory oversight facing large and small companies
- Anticipate circumstances where smaller companies may be able to “fly under the radar”
- Train new hires on direct involvement in tactical operations that they may have delegated to others at prior jobs
Many PRCs struggle with a confrontational culture. This can be managed by making sure each sector understands the value of the other; but such understanding can be tough to communicate, especially when you are doing multiple reviews in sequence. You need to proactively take the time to set up the right culture for your committee.
- Make sure all reviewers see themselves as advisors and contributors rather than internal regulators
- Bring team members’ attention to “default” behaviors that may need updating
- Clearly communicate expectations for teamwork and dialogue to all new reviewers