Now that everybody has calmed down about my April Fools joke (ie, “FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media!“), we should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.
I suggested this in yesterday’s post (see “FDA and Pharma – Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!“) because it seems that the FDA and some pharma companies are “mulling” this over behind closed doors and I want those doors opened.
What do you think?
I have a survey to get your opinion, but first let me explain FDA’s procedures for developing and issuing guidance documents, using its own words (see here for the Full Monty):
What is a guidance document?
“Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue.”
“Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.”
I emphasized “can” because FDA doesn’t always seek or accept input form the public, as in:
“FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.”
My opinion is that we need to make sure that the FDA DOES determine that public participation is both “feasible” and “desirable.” As I mentioned in yesterday’s post, there is a precedent for holding a public hearing on Internet issues prior to issuing guidance (see here). However, the FDA chose NOT to issue any Internet guidance after that public hearing. Therefore, even if we win the battle to get a public hearing, we must make sure that the FDA follows up with guidance on social media that takes public comments into account.
When the FDA goes the non-public route in issuing guidance, here’s the procedure:
“FDA publishes a notice in the Federal Register announcing that the guidance document is available; it posts the guidance document on the Internet and makes it available in hard copy; it immediately implements the guidance document; and it invites your comment when it issues or publishes the guidance document. …If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.”
Obviously, it’s much more difficult to revise public documents after the fact. It’s much better to get involved at the start when making gov’t sausage!
The Survey
OK, that’s the background. My survey presents you with several different procedures the FDA could use to develop guidance for the use of social media for the promotion of drugs and other medical products it regulates. These are:
- Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
- FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
- FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
- If FDA solicits public comments — no matter in what fashion — it should publish ALL the comments it receives.
Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.
