Writing after marketing authorisation
Writing for a medicine does not stop at its approval. After the initial submission come reports on further studies, safety reports and new indications, and with them the questions of who writes once the original team has moved on, what pressures the drafting faces, and what part a strategic writer takes in the post-authorisation safety documents.
What post-approval writing covers
In one experienced writer's view, clinical development is very often focused solely on gaining marketing authorisation, and the documents written afterwards were perhaps seen as a necessary evil, a drain on resources with no return on investment. In the years up to 2014 that documentation underwent something of a renaissance, driven by the 2012 change in pharmacovigilance legislation and, the same writer believes, by a rising demand for high-quality information from patients, lobbyists and support groups. The same writer argues that a medical writer's job does not finish with the study reports, the dossiers and the answers to the authorities' questions, because writers are needed as much to keep a drug on the market as to get it there.
Writing the reports contained in a Common Technical Document that a sponsor submits to the regulator is pre-approval writing, and writing after that initial submission, in response to the regulator's assessment or as part of research and development for other indications, is post-approval writing. Its reports include those for studies the health authority requested, typically post-authorisation safety studies, and safety-related reports such as periodic safety update reports and risk management plans. They also include reports for studies conducted to extend the indication to other populations: a drug first approved for adult patients with essential hypertension without comorbid conditions might later be tried in children, in hypertension due to secondary causes, in pregnancy, in the elderly, or in patients with comorbid conditions such as diabetes mellitus or heart failure.
A large part of drug development continues after the sponsor applies for approval of a drug in an indication. The clinical development plan is the blueprint the sponsor uses to plan and conduct the research and development needed for approval in a particular indication, and the sponsor uses it to strategise and prioritise the parts needed for that initial approval while the other parts are planned later, for the registration of other indications. The sponsor wants to identify other unmet medical needs the approved drug can fulfil, and it might file for claims in another indication immediately after the initial approval, or only after a longer period of research and development and of experience from marketing the drug.
Who writes after submission
Once a submission is done, the team, including its writers, is usually reassigned to other tasks, and reassignments are part of business as sponsors try to manage their resources and the risk associated with some of those reassignments. A writer involved from the start can help bring perspectives from the earlier documents and keep the post-approval documents in step with those already submitted. A new writer needs time to start contributing effectively, because they have to do their homework on the reports written earlier and on how those bear on the task at hand, but brings a new perspective and the experience and strategies of other submissions. The sponsor decides on resource optimisation and the project's priority, and that decides who writes the documents.
Writing in continuity after the initial submission works well for the sponsor as long as other claims for the drug are planned. Where new studies are conducted long after the initial submission, with the drug already on the market, the team that worked on the initial submission cannot always take part. The challenge for the team that does take part is to ensure that the data from the initial research are supplemented with the marketing experience, and that the safety and efficacy data are based on the drug's use in the population.
Pressures on the drafting
Post-approval writing can present situations and challenges to the sponsor and the writer, and a writer should be aware of them and plan to surpass them, working with experts in different domains so that the right drug reaches the right patients in time.
Writing for a study the health authority mandated as a condition of approval has to reach the regulators within the stipulated time, to avoid delaying the planned marketing of the drug to patients. A writer drafting a report on a study conducted in an indication other than the approved one has to think carefully about presenting all the relevant efficacy and safety data well, without leaving room for an interpretation that some information is missing, because such an interpretation can affect the drug's marketing status in its primary indication. The writer, along with the report's other authors, should also evaluate how the new information fits with the information from the initial submission that the regulators already hold, and whether it contradicts or agrees with the results of the pre-approval studies. This is extremely challenging, because the report should always be written to avoid any scope for misinterpretation, even when the new information puts the drug's marketing status in the primary indication at stake.
Writing before approval and writing after it each has its own set of challenges, and planning and carrying out either calls for expertise and strategic approaches.
The strategic writer in post-authorisation documents
The strategic medical writer has a key position in producing and submitting the post-authorisation documentation that followed the 2012 legislation, because that documentation carries more complex data in larger amounts, requires greater detail, additional analysis and input from different specialities, and still has tight deadlines. The significant changes in post-authorisation documentation give the strategic writer the opportunity to become an invaluable link in the team. The strategic writer contributes document expertise, scientific expertise, writing skills and project leadership to these documents, through effective communication.
The strategic writer provides a central link for all members of the team in developing post-authorisation documents, by anticipating problems, managing the review process, advising on data presentation and ensuring compliance with the guidelines. The strategic writer also has a significant responsibility for ensuring the accuracy of information and compliance with the regulations, as well as for data interpretation and project management.
A problem frequently encountered in producing post-authorisation documents is essential data arriving late, or incorrect data, meaning data that do not entirely encapsulate what a particular section of the document requires, which puts extreme pressure on the team to meet the submission deadline. Through collaboration, support and coordination with the team, the strategic writer can pre-empt this by producing a list of the data required and the timescales involved as far in advance as possible, then checking the progress of data production through regular communication with the departments and team members involved, which reduces the likelihood of late or incorrect data. For a periodic safety update report, the writer can assist the marketing authorisation holder by being involved from the very beginning of the process and advising on the problems that may arise, such as late data or essential information not available when required, and on their impact on the very tight timelines.
The new requirements for the risk management plan challenge the industry to prepare a document that incorporates all of the required legislation, and the strategic writer can help by advising on templates and ensuring that the chosen template meets that legislation. For the new-format periodic safety update report, the writer can add value by advising on how to interpret the guidelines in order to produce the template, and by suggesting the best format in which to present the data. Producing a risk management plan requires input from different specialists, such as pharmacologists, clinical research physicians, pharmacovigilance experts and toxicologists, and the strategic writer's role includes coordinating the team and managing the review cycles. That means ensuring that the correct data arrive on time and that each specialist's input is received, reviewed and included in the document appropriately.
According to one practitioner, this contribution results in high-quality documents, ensures a smooth submission process, facilitates the strengthening of the pharmacovigilance system and ultimately contributes to patient safety.