I am not a huge fan of PDUFA. It puts the wrong cast on things. Fees are something I pay for a service, and it should put me in the driver’s seat (well except for airlines and everyone hates that). We tax for government services. Making the FDA dependent on pharma creates an imbalance in power that quite frankly shouldn’t exist.
The extent of statutorily required industry input in the drug regulation and reauthorization processes has increased as a result of the PDUFA reauthorization. The centrality of user fees to the modern FDA has led some observers to express concern that they have contributed to “corrosive capture” of the agency (i.e., a weakening of regulatory independence and of the ability of the agency to uphold traditional efficacy and safety standards) by shaping discourse about how drugs should be regulated or by enabling an unhealthy culture of closeness between the FDA and industry. Each successive PDUFA has required the FDA to be increasingly responsive to industry concerns.
The FDA plays a crucial role in protecting the health of the public while approving new treatments in a timely fashion. Thirty years of experience with user fees has shown that, in the face of inadequate public funding of the personnel budget of the FDA, increased funding by its egulated industries can indeed improve regulatory timelines. This increased speed has also raised questions related to the decisions being made and the growing reliance of the agency on financial support from the companies it regulates, as the user-fee model has fundamentally changed the way that the FDA interacts with industry. In a different political climate, adequate public funding in place of user fees would allow the FDA to continue its current performance levels while adding further confidence that the public remains the primary client of the FDA.
Teams and Work-Groups need ground rules, they should have a charter, which includes a nice vision of how the team sees itself.
Let’s be honest, we do not spend enough time building and maintaining these charters. If you are like me you tend to dive right in, and that will always cause some problems. Luckily, it is never too late to take a step back and do the work.
Start by answering these eight questions about the team and its place in the organization.
Consistency with organizational objectives: The team vision should be aligned with and derive from the organization’s overall purpose and strategy. Teams are sub-elements in a wider organization structure and their success will be judged on the extent to which they make valuable contributions to the overall purpose of the organization. In some circumstances, a team may decide that it is important for its own values, purposes, and orientations to act as a minority group that aims to bring about change in organization objectives – perhaps like a red team.
Receiver needs: How a team focuses on providing excellence in service to their customers, whether internal or external.
Quality of work: A major emphasis within organizations is the quality of work. The relationship between quality and other functions like efficiency is important.
Value to the wider organization: Understanding the importance of the team just not for the wider organization but beyond, leads to team cohesion and greater team effectiveness. Team members need a clear perception of the purposes of their work.
Team-climate relationships: Team climate refers to aspects such as warmth, humor, amount of conflict, mutual support, sharing, backbiting, emphasis on status, participation, information sharing, level of criticism of each other’s work, and support for new ideas.
Growth and well-being of team members: Growth, skill development and challenges are central elements of work-life, and teams can be a major source of support. Teams provide opportunities for skill sharing and support for new training. Teams need to be concerned for the well-being of their members, including things like burnout.
Relationships with other teams and departments in the organization: Teams rarely operate in isolation. They interact with other team and departments within the organization. Teams must be committed to working effectively and supporting other teams. Avoid silo thinking.
From there you can then generate the 10 aspects of the charter:
Team Ground Rules: What positive behaviors/values will the team seek to embrace and exemplify?
Trust Damagers and Destroyers: What negative behaviors would damage/destroy trust in the team and how will the team avoid/deal with these?
Conflicts of Interest: Are there any possible conflict of interest scenarios and, if so, how should they be handled?
Team Boundaries: What are the boundaries of the team and the different types of team participation?
Information Sharing: Where will there be transparency of information sharing and where will there be privacy and restricted sharing within the team?
Issue and Conflict Resolution: How will issues and conflicts be resolved?
Meetings: Type, frequency, purpose, attendees and channels
Induction, Mentoring, Buddying: How (and if) will new members be brought into the team?
Communications: What tools will be used for communications and what are the agreed to “Reply-by” times
Do not short communication
How much time do you spend communicating every day? Whether this is through phone calls, IM, texts, email, written reports, face-to-face conversations, or meetings, many of us spend a large proportion of our day dealing with messages that demand our attention.
Be deliberate in how we manage these interactions so that people communicate efficiently and effectively. Outline preferred methods of communication, how to use different channels effectively, and what people want to achieve. By improving communication you can drive for effective meetings, reduce the volume of emails, ensure that exchanges are professional, and free up time for high-value tasks.
Include the following in your communication section:
When people need to reply to emails and when they don’t.
When people should “Reply All” to emails and when they should avoid it.
How to organize regular team meetings, who should attend, whether people will “dial in” remotely, what to include in the minutes, who will circulate them, and so on.
How your team communicates with customers internal and external.
How team members interact on internal social media (chat, slack, etc).
When making a video or audio call is appropriate.
How people engage with others face-to-face.
Signs of Team/Work-Group Misalignment
There are some behaviors to look out for, when you see them, it’s time to return to the charter, and improve.
Vague Feelings of Fear. You know what the team is supposed to deliver on, but you don’t know how exactly you’re supposed to work with anything in your power or control to “move the needle.”
Ivory Tower Syndrome. Things aren’t clear or different people have different expectations for a project or initiative. No one is really able to clarify.
Surprises. Someone committed you to a task, but you weren’t part of that decision.
Emergencies. How often are you called on to respond to something that’s absolutely needed by close of business today? How often are you expected to drop everything and take care of it? How often do you have to work nights and weekends to make sure you don’t fall behind?
Cut Off at the Pass: Someone else is doing the same work unaware to all.
Not Writing Things Down. You have to make sure everyone is literally on the same page, seeing the world in a similar enough way to know they are pursuing the same goals and objectives. If you don’t write things down, you may be at the mercy of cognitive biases later. How do you know that your goals and objectives are aligned with your overall company strategy? Can you review written minutes after key meetings? Are your team’s strategic initiatives written and agreed to by decision-makers? Do you implement project charters that all stakeholders have to sign off on before work can commence? What practices do you use to get everyone on the same page?
Nothing new here really, as the FDA has just finalized recommendations that companies make adequate preparations to operations in advance of when a recall may be needed (e.g., prepare and execute a recall communications plan). In addition to these preparations, the FDA recommends that companies consider preparing, maintaining, and documenting written procedures (in paper or electronic format) for initiating a recall and performing actions related to initiating a recall. Moreover, the document addresses how companies should develop a recall strategy and train personnel on executing a recall, as well as how companies should use adequate product coding.
Luis Charles Chavarría recently posted about watches and quality. Reading that, and several of the responses remind how pharmaceutical quality is often just framed in terms of regulatory adherence instead of a broader approach. ISO9001 and other major quality models basically break down to having 8 dimensions of quality.
8 key dimensions of Quality
In a lot of industries, it is very visible to the customer whether quality exists. Shoes, cars, toaster ovens – I can gauge them based on multiple of the criteria above before I buy. I can go on credible review sites, use tools like Consumer Reports, get reliable feedback from others. When a friend recommends a couch, I can trust their opinions.
We have none of that in the regulated areas of pharma and much of medical devices. Patients are prescribed product, and even when there are multiple generics available the only real criteria is price. Chances are the patient barely knows the manufacturer, let alone the manufacturing site. It can be very difficult for a patient, or even doctor, to gauge the quality of the product.
It is for this reason we need more transparency throughout the supply chain, through the development of products. The National Academies of Science, Engineering and Medicine (NASEM) report is a start and needs to be implemented quickly. As a beginning it can really help start to shift the needle and make large parts of this industry more receptive to
