Saturday, March 11, 2017

Dr. Scott Gottlieb may not be the friend the compounding pharmacy industry has hoped for at the FDA; Here is the testimony he has given before Congress in the past on the subject

STATEMENT OF SCOTT GOTTLIEB

    Dr. Gottlieb. Thanks a lot, Mr. Chairman Pitts, Mr. Ranking 
Member Pallone, and members of the committee. Thanks for the 
opportunity to testify today. I have a longer statement for the 
record. I would like to summarize a few key points for you this 
morning.
    The tragic deaths of 55 Americans and the sickening of more 
than 740 resulting from contaminated steroid injections that 
were shipped by a disreputable firm have rightly focused public 
attention on a largely unfamiliar but prominent part of the 
drug supply chain, the practice of pharmacy compounding.
    Before this Congress are proposals to tighten Federal 
regulatory oversight of these compounding pharmacies and the 
practice of pharmacy more generally. Observers are calling on 
Congress to give the FDA more oversight of these firms. New 
laws merit consideration. We should articulate clear and bright 
lines between a legitimate practice of pharmacy compounding and 
those firms operating illegally as large-scale manufacturers 
under the guise of a pharmacy license. Some key considerations 
should, in my opinion, guide this work.
    First, there exists a practice of pharmacy. It was never 
intended that all compounding would create a new drug and be 
subject to FDA regulation but for the enforcement discretion or 
for the willingness of Congress to provide explicit exemption 
to certain pharmacists and certain activities that pharmacists 
undertake.
    Second, FDA has authority to target compounders that cross 
the line between the practice of pharmacy and engage in drug 
manufacturing under the guise of a pharmacy license. What FDA 
largely lacks is ease of administering this authority. FDA is 
generally not able to force firms to submit advance information 
to the agency before the firm is suspected of any wrongdoing, 
and so that the agency is more efficiently able to identify 
firms engaged in wrongdoing and target its oversight.
    Third, FDA generally lacks tools and resources to regulate 
a new class of firms that the agency has dubbed nontraditional 
compounders. I would argue that the firms in question here are 
not compounders, and calling them such confuses different 
issues. Rather, they are engaging in the bulk, large-scale 
repacking and manufacturing of sterile preparations of FDA-
approved drugs, typically in advance of and often not in 
response to prescriptions for individual patients.
    To the degree that these large-scale operations prepare 
sterile volumes of drugs in a bulk form and ship these units 
widely, they present some novel risks and they have the 
potential for what I would call distributed risks. The public 
health could benefit from applying additional oversight to 
these firms, especially requirements that they adhere to good 
manufacturing practices.
    Fourth, as we address issues of supply, we must also 
address the policy decisions that have increased demand for 
products from some disreputable firms, from large-scale 
compounders who are breaking existing law and violating 
existing regulations. For example, the recent crackdown on 
manufacturing of generic drugs have shifted a lot of the demand 
for generic preparations to compounders. Likewise, decisions by 
FDA to suspend enforcement against compounders in certain 
select situations where the agency and policymakers had 
concerns about the high cost of FDA-approved drugs relative to 
the low costs of compounded versions has also given greater 
license to certain compounders to bend, if not break existing 
law.
    Consistent enforcement is going to be especially important 
if we create a new class of compounders that FDA has dubbed the 
nontraditional compounding. If FDA doesn't exercise its 
enforcement evenly and consistently, which means not allowing 
firms to compound identical versions of FDA-approved products, 
then the agency will give more incentive for drug makers to 
remask themselves as nontraditional compounders to skirt FDA's 
new drug requirements.
    Finally, the market for compounding drugs is evolving very 
quickly. It is consolidating as other entities like 
distributors could well start buying out the large compounders. 
As this process unfolds, it will leave behind a much different 
compounding industry. This should serve as a cautionary tale to 
all of us. We should be mindful that the rules that we might 
write today would no longer be applicable to the market that we 
see tomorrow.
    Thank you for the opportunity to testify this morning. I 
look forward to your questions.
    Mr. Pitts. Thank you, Dr. Gottlieb.
    [The prepared statement of Dr. Gottlieb follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

quoted from   HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE  COMMITTEE ON ENERGY AND 
COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS FIRST SESSION

MAY 23, 2013 Serial No. 113-48

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