US FDA reviews all existing drug rules to make them more effective
This article was originally published in SRA
The US Food and Drug Administration has announced a review of all its existing drug, medical device, food and tobacco regulations to determine whether they can be made more effective in light of current public health needs and to support advances in innovation1,2.
Stakeholders have until 27 June to submit comments and supporting data on which, if any, of FDA's existing regulations are outmoded, ineffective, insufficient or excessively burdensome and may thus be suitable for modification, streamlining, expansion or repealing. The review is for published final rules only and stakeholders should not use this process to submit comments on proposed rules.
While the FDA carries out regular periodic reviews of its existing regulations, the latest move is triggered by an executive order issued by President Barack Obama earlier this year3. Under the provisions of the executive order, the FDA is reviewing its framework for retrospective review of regulations and is seeking feedback on ways to make the programme more effective.
The FDA is particularly interested in how well its current processes for reviewing regulations function and how those processes might be expanded or otherwise adapted to meet the objectives of President Obama's executive order. The agency is further interested in receiving comments about factors that it should consider in selecting rules for review and prioritising review.
In addition, it is seeking comments on how best to evaluate and analyse regulations to expand on those that work and to modify, improve or rescind those that do not. To be useful, the FDA says, comments should address how the agency can best obtain and consider accurate, objective information and data about the costs, burdens and benefits of existing regulations and whether there are existing sources of data that the FDA can use to evaluate the post-promulgation effects of regulations over time.
The FDA is interested in comments that identify regulations that may be "impediments to innovation" and suggestions for how they can be improved. When submitting responses, the FDA wants stakeholders to ensure their comments focus on regulations that have demonstrated deficiencies. Comments that reiterate previously submitted arguments relating to recently issued rules will be less useful.
The comments should include details of the specific regulations that stakeholders believe need to be changed, strengthened, clarified or revoked. Explanation of why the change or revocation is necessary or desired will be helpful if coupled with specific recommendations to improve the regulation, particularly any specific language modifications, the agency says.
References
1. Federal Register, 27 April 2011, 76(81), 23520-23522, http://edocket.access.gpo.gov/2011/pdf/2011-10131.pdf
2. FDA Transparency Blog, What needs fixing and how can we fix it? 26 April 2011, http://fdatransparencyblog.fda.gov/2011/04/26/what-needs-fixing-and-how-can-we-fix-it/
3. Obama gives US FDA, other agencies 120 days to review regulations, Regulatory Affairs Pharma, 20 January 2011