New Directions for FDA, Part 2 – Regulatory Matters

In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could bring change to FDA. There is the regulatory side of things as well.

Just prior to the election, the President-elect made the statement that he would be aiming to cut 70-80 percent of government regulations. While presumably he is aiming at regulations put into place that affect business and finance practices and enforcing legislation such as Dodd-Frank and also at EPA environmental regulations.

While remarks made during the campaign indicate that the pharmaceutical industry is a concern of his with respect to pricing, when it comes to matters outside of pricing, the new Administration may be willing to alter regulations that it considers to be in the way of businesses doing their business. Therefore, it is not inconceivable that a part of the aspirational regulatory elimination that could result might be aimed at at least some of the regulations issued involving the agency that regulates one in five of every dollar spent in this country – the Food and Drug Administration.

FDA naturally involves a great deal of regulation. What might be prime targets for change?

  • Off-label Promotion – Much has been done and written over the years about what industry can and cannot do with respect to off-label promotion, making it one of those issues that is never completely settled. Industry has often made clear a desire a more loose approach with respect to off-label promotion and has successfully pushed back against FDA stringent position on the matter through the courts, opening the way for a greater sharing of scientific information regarding investigation into additional uses for approved medicines. At a recent two-day hearing by FDA entitled Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, some within industry reportedly made the case that they should be allowed to share off-label information with payers. Opponents expressed concern that by-passing FDA in this manner could limit physician choice in prescribing. Notably, this is an issue not addressee by the 21st Century Cures Act.
  • Promotion in General – Discussion of off-label usage is one aspect of FDA regulation over the commercial speech related to its medical products, but there are many, many more. It is not inconceivable that a new FDA commissioner might make enforcement even less of a priority than it has been from the Office of Prescription Drug Promotion (OPDP) – the office which oversees promotion and advertising of approved medicines and devices. As noted many times on this blog, promotion has been fairly anemic the past few years – and no more so than this year with the issuance of a mere five (5) letters issued by that office. OPDP has implied enforcement has taken other forms, but not offered any transparency whatsoever regarding what activity that entails. While anemic, it is possible that enforcement over promotional activities may become even less of a priority in an Administration that regards regulations as too abundant and that promotes its intentions as “business friendly”. In short, promotion of unapproved drugs, unsubstantiated claims may find a less strict environment.
  • Guidance – That may translate not only into less enforcement, about promotion but less guidance about promotional activities as well. It has taken FDA years to enunciate guidance with respect to communications via social media. And while such guidance has been very difficult to pry out of FDA and OPDP (still waiting on many aspects, including fleshed out thinking on the use of links related to risk information and adverse events reporting left vague and incomplete by guidance documents so far), more guidance in this area may not be a priority for the incoming Administration.

There are likely many other ways in which a regulatory cutting zeal on the part of the new Administration might impact FDA – there might be fewer inspections for example. But the nature of this blog is to focus on those issues that impact communications and so speculation will go no further. The game of prediction – as the election cycle demonstrated – is a tricky business and one goes out on a limb when speculating on specific outcomes. But one safe bet – if there is truly a desire to cut regulations, the agency that oversees one-fifth of the US economy is not likely to be exempt.

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