White House Launches Effort To Revise Biotechnology Regulation

While I find the timing suspect, on Thursday John Holdren, Director of the White House Office of Science and Technology Policy (OSTP), announced (along with other senior White House staff) the Administration will be reviewing the Coordinated Framework for the Regulation of Biotechnology, the policy that designates agency responsibilities for overseeing the introduction of biotechnology products into the environment (H/T Grist).  First developed in 1986, the last revision was in 1992.  So, clearly overdue.

Holdren’s announcement accompanied a memorandum to the Environmental Protection Agency, the Department of Agriculture and the Food and Drug Administration.  It (along with Holdren’s blog post) outlines the elements of the review process:

  • Updating the Common Framework (with public input) to clarify the biotechnology product areas (not processes) for which each agency will be responsible.  This will include how to handle situations where more than one agency may be responsible.
  • Developing a long-term strategy (with public input) to ensure that the Federal regulatory process will be better prepared for emerging biotechnologies.  This would include horizon scanning exercises and additional support of so-called ‘regulatory science.’
  • An independent examination of the future landscape of biotechnology.  The National Academies have already been engaged to start this analysis.

This all sounds great, but there are some aspects of this that give me pause.  First, the announcement comes the afternoon before the July Fourth holiday weekend.  It screams news dump – an effort to ensure that very few people become aware of the effort.

Additionally, while the revisions and the strategy will involve public input, Holdren asks for people interested in additional information to register.  If this wasn’t already part of an announcement that seems timed to minimize public reception, I might not think much of it.  But I can see the Administration limiting its subsequent publicity on this project to the people who register.  If they are going to try and hold listening sessions around the country (the first one will take place this fall), I think they should spread their message far and wide.

Finally, I guess I’m still a bit chagrined from other efforts to revise (or develop) regulations related to science and technology research.  The effort to revise the Common Rule related to human subjects research stalled out after a big public comment push in 2011.  And it still seems as though the push on scientific integrity policies has failed mainly from a lack of coordinated follow-through from the OSTP.

I’d love to see this not happen with the revisions to the Coordinated Framework, but I’m not optimistic – especially with roughly 18 months to go with this Administration.

U.S. Government Not Keen On Germ-Line Editing, At Least Right Now

Yesterday John Holdren, Director of the Office of Science and Technology Policy (OSTP), posted to the OSTP blog about recent activities in genome editing.  While the Chinese effort to conduct genome editing in human embryos attracted headlines and an announcement from the National Institutes of Health stating it would not fund similar research, it was not the specific focus of the statement.

That was reserved for the recent announcement that the National Academy of Sciences and the National Academy of Medicine (the new name of the Institute of Medicine) launched an initiative to address these technologies.  The initiative will include an international meeting this fall, along with a committee to study gene-editing technologies and an advisory board to guide the effort.  The project will include, technical, social, legal and ethical issues related to these technologies.

Dr. Holdren’s blog post and the Academies’ announcement noted the historical precedents for this kind of a priori assessment, including the restrictions imposed on recombinant DNA research, gain-of-function research, stem cell research and human cloning while researchers and policymakers discussed the implications of that work.

While not going so far as to echo calls for a moratorium on germline genetic editing, Dr. Holdren’s blog post can be read to imply Administration support for such a move.

“The White House applauds NAS and NAM for convening this dialogue and fully supports a robust review of the ethical issues associated with using gene-editing technology to alter the human germline. The Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”

Given the nature of how the National Academies typically prepare their study committees, the international meeting this fall will more likely be the start of its process rather than a culmination.  I would also not be surprised to see the Presidential Commission for the Study of Bioethical Issues engage with these technologies, either through its own initiative or a request from the President.

If You’re Too Lazy To Drink Your Alcohol

Last year I posted about Palcohol, a powdered alcohol that was approved by the Alcohol and Tobacco Tax and Trade Board, but that approval was short-lived due to problems with the product labels.

Proper approval came through yesterday, making it legal to sell Palcohol in the United States.  The manufacturer has taken pains on the website to assure people that the product cannot be abused (not that people won’t try).  That the size and volume of the product necessary for spiking beverages, getting drunk and or smuggling it is too much to make it a practical method of abuse.

I am intrigued by the purported beneficial uses of the product that aren’t just making it lighter and easier to pack alcohol.  An ‘industrial formulation’ of the product could allow for easier forms of antiseptic, fuel, and other non-consumable applications for alcohol.

However, the industrial formula was not the one approved for sale.  The flavored versions of powdered alcohol have attracted the attention of several state legislatures, which are working on banning the sale of powdered alcohol.  Two states, Alaska and Delaware, already have laws on the books that cover powdered alcohol (for human consumption).

So, unless your state works to ban the product by the summer, you should be able to get your powdered drink on later this year.

Appointment Heading For The Exits

While the confirmation challenges continue, at least one high-level science and technology appointee is stepping down.  Margaret Hamburg, Commissioner of the Food and Drug Administration, will step down at the end of next month (H/T ScienceInsider).  Even with slightly less than two years remaining in the Obama Administration, there is a chance Dr. Hamburg’s successor may not be confirmed before a new President is sworn in.  (I am encouraged by indications that a nominee has already been identified.)

Hamburg’s tenure is one of the longest in the agency’s history.  When she took over, the agency was struggling, with ethical challenges over drug approvals.  The agency is currently in the middle of regulatory changes for food safety oversight and medical device approvals, and it has not been perfect.  There were complaints over the agency’s inaction over compounding pharmacies (which are not presently regulated by the FDA), and Hamburg was overruled by Health and Human Services Secretary Sebelius over Plan B emergency contraception (though the courts eventually sided with the FDA).

NSF Changes Transparency And Accountability Procedures

The National Science Foundation (NSF) announced in early December changes to its accountability and transparency procedures.  Based on some of the changes, it would appear that the move is also in response (see the third paragraph) to the Republican congressional efforts to explicitly connect individual grants to ‘the national interest.’

The changes are focused on how projects are described in grant proposals and abstracts.  While that may appear superficial, it’s worth remembering that most policymakers and members of the public will only encounter brief descriptions of scientific projects.  Like an abstract.

So, effective December 26, the NSF Proposal and Awards Policies and Procedures Guide was updated to reflect the following (quoting from the press release):

“Should a proposal be recommended for award, the PI may be contacted by the NSF Program Officer for assistance in preparation of the public award abstract and its title. An NSF award abstract, with its title, is an NSF document that describes the project and justifies the expenditure of Federal funds.”

“The guidelines for program officers in the Proposal and Award Manual now state that a nontechnical project description must explain the project’s significance and importance and “serve as a public justification for NSF funding by articulating how the project serves the national interest, as stated by NSF’s mission: to promote the progress of science; to advance the national health, prosperity and welfare; or to secure the national defense.” The titles and abstracts of NSF’s awards are made public on NSF.gov.”

What would be lovely to see is the commencement of a research program to assess how these new requirements are implemented, and how views of titles and abstracts change (if they do).  Will these new requirements be handled in the same way the ‘broader impacts’ requirements have been?  Will Congressional efforts to micromanage grant approvals make use of this information?

NIH IRB Proposal Reflects Proposed Common Rule Changes

The National Institutes of Health (NIH) has issued a request for comments on a draft policy concerning Institutional Review Boards (IRB).  The NIH proposes allowing multi-site research studies to use a single IRB for approval.  The idea is that concentrating the human subjects review approval to one IRB would reduce the administrative burden.  It is even possible that a single IRB review for multi-site research might increase protections by focusing the oversight to a single body.

Comments are accepted on the policy through January 29, 2015.

This draft policy reflects changes proposed in 2011 when the Department of Health and Human Services proposed changes to the Common Rule – the suite of regulations on oversight of human subjects research.  IRB approval is just one facet of those changes, so maybe there are additional policy proposals coming.  Even in today’s dysfunctional environment, 3 years is a long time to wait.

Clinical Trials Data May Get More Transparent

The Department of Health and Human Services (HHS), the parent department of the National Institutes of Health (NIH), has issued proposed rules concerning the transparency of clinical trials data (H/T Nature News, ScienceInsider).  The proposed rules should be published in the Federal Register soon, and with the 90 day comment period, submissions will likely be due around February 19.  NIH also released a Draft Policy, and is asking for comments by February 19.

The proposed rules are quite lengthy (over 400 pages); so lengthy that it might be folly to consider the NIH Draft Policy as an effective summary.  The main purpose of both is to increase the amount of data that is reported and available to the public (through ClinicalTrials.gov).  Adverse effects and negative results would be disclosed under these proposed policies.

However, as NIH Director Collins explains in a blog post, the NIH policy goes further than the HHS proposed rules.  The policy would apply to all clinical intervention trials that NIH funds (not just drugs), while the HHS rules are focused on summary data of certain clinical trials for drugs and therapies.

While an intention behind both policies is to close reporting loopholes, it’s not clear how effective the new policies will be in addressing the significant under-reporting of clinical trials data.  Ideally more results will be submitted to ClinicalTrials.gov and more results will be made available faster than they currently are.  But reporting on these policies suggests that the amount of data still not reporting is quite large, and these new policies may make only a dent.