Court filing

FDA's answer to complaint — PHMPT v. FDA

Filed October 18, 2021 in Public Health and Medical Professionals for Transparency v. Food and Drug Administration; one of 30 filings from this case.

Record facts

Court	U.S. District Court for the Northern District of Texas
Filed	2021-10-18

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 14 · 2021-10-18 · Docket on CourtListener

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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
____________________________________

)
PUBLIC HEALTH AND MEDICAL
)
PROFESSIONALS FOR

)
TRANSPARENCY,

)
)
Plaintiff,

)
)
v.

)
Civil Action No. 4:21-cv-01058-P
)
UNITED STATES FOOD AND DRUG
)
ADMINISTRATION,

)
)
Defendant.

)
___________________________________ )

ANSWER TO PLAINTIFF’S COMPLAINT

Defendant, the U.S. Food and Drug Administration (“FDA”) by and through undersigned
counsel, hereby answers the Complaint (ECF No. 1) (“Complaint”) filed by Plaintiff Public Health
and Medical Professionals for Transparency (“PHMPT”) on September 16, 2021, as follows, in
correspondingly numbered paragraphs:
1.
Admitted that until August 23, 2021, all vaccines legally available to the public for the
prevention of COVID-19 in the United States were authorized by FDA under emergency
use authorization. Except as so expressly admitted, the allegations of paragraph 1 are
denied.
2.
Admitted.
3.
The allegations in first two lines of this paragraph purport to characterize a news release
by FDA, which speaks for itself. To the extent that Plaintiff’s allegations are
inconsistent with the news release, the first two lines of this paragraph are denied. The
rest of the paragraph consists of Plaintiff’s characterization of alleged “questions” raised
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by unnamed individuals about which Defendant lacks knowledge or information
sufficient to form a belief about the truth of the allegations.
4.
This paragraph consists of Plaintiff’s characterization of itself and its work. Defendant
lacks knowledge or information sufficient to form a belief about the truth of the
allegations in this paragraph.
5.
The first sentence of this paragraph consists of Plaintiff’s characterization of itself and
its work. Defendant lacks knowledge or information sufficient to form a belief about
the truth of the allegations in the first sentence of this paragraph. Allegations in the first
sentence of this paragraph also purport to characterize a website by FDA, which speaks
for itself. To the extent that Plaintiff’s allegations are inconsistent with the website, the
first sentence of this paragraph is denied. By way of further response, FDA avers that
it is committed to transparency while appropriately protecting confidential information.
The allegations in the second sentence of this paragraph set forth Plaintiff’s conclusions
of law, to which no response is required. Furthermore, the allegations in the second
sentence of this paragraph purport to characterize 21 C.F.R. § 601.51(e), which speaks
for itself. To the extent that Plaintiff’s allegations are inconsistent with the regulation,
the second sentence of this paragraph is denied.
6.
Defendant admits this paragraph and avers that footnotes 5 and 6 of Plaintiff’s
Complaint are copied verbatim from footnotes 1 and 2 of Plaintiff’s Freedom of
Information Act (“FOIA”) request. Defendant respectfully refers the Court to the FOIA
request dated August 27, 2021, for a full and accurate statement of its contents. See
Compl. Exh. A.1.
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7.
This allegations in this paragraph sets forth Plaintiff’s alleged motivations for its FOIA
request about which Defendant lacks knowledge or information sufficient to form a
belief about the truth of the allegations. They do not set forth a claim for relief or aver
facts in support of a claim to which a response is required. Furthermore, the allegations
in this paragraph consist of Plaintiff’s opinions rather than facts, as well as speculation,
such that Defendant lacks sufficient information to admit or deny.
8.
Admitted that Plaintiff requested expedited processing of its FOIA request. The rest of
the allegations in this paragraph purport to characterize Plaintiff’s FOIA request, which
speaks for itself. Defendant respectfully refers the Court to the FOIA request dated
August 27, 2021, for a full and accurate statement of its contents. See Compl. Exh. A.1.
9.
Admitted that FDA denied Plaintiff’s request for expedited processing. The rest of the
allegations in the first sentence of this paragraph purport to characterize FDA’s letter to
Plaintiff, which speaks for itself. Defendant respectfully refers the Court to FDA’s letter
dated September 9, 2021, for a full and accurate statement of its contents. See Compl.
Exh. A.4. The second sentence of this paragraph consists of Plaintiff’s characterization
of this action, to which no response is required.
10.
This paragraph consists of Plaintiff’s characterization of itself and its work about which
Defendant lacks knowledge or information sufficient to form a belief about the truth of
the allegations.
11.
This paragraph consists of Plaintiff’s characterization of itself about which Defendant
lacks knowledge or information sufficient to form a belief about the truth of the
allegations.
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12.
The allegations in the first sentence are admitted. The second sentence consists of
Plaintiff’s legal conclusions to which no response is required.
13.
This paragraph consists of Plaintiff’s legal conclusions regarding jurisdiction and venue,
to which no response is required.
14.
Admitted.
15.
The allegations in this paragraph consist of Plaintiff’s characterization of “an ongoing,
public national debate” by unnamed individuals about which Defendant lacks
knowledge or information sufficient to form a belief about the truth of the allegations.
16.
This paragraph consists of Plaintiff’s characterization of alleged “declar[ations]” by
unnamed individuals about which Defendant lacks knowledge or information sufficient
to form a belief about the truth of the allegations.
17.
The allegations in this paragraph purport to characterize a news release by FDA, which
speaks for itself. To the extent that Plaintiff’s allegations are inconsistent with the news
release, this paragraph is denied.
18.
The allegations in this paragraph purport to characterize a news release by FDA, which
speaks for itself. To the extent that Plaintiff’s allegations are inconsistent with the news
release, this paragraph is denied.
19.
The allegations in this paragraph purport to characterize a news release by FDA, which
speaks for itself. To the extent that Plaintiff’s allegations are inconsistent with the news
release, this paragraph is denied.
20.
The allegations in this paragraph purport to characterize an article by CBS News, which
speaks for itself. To the extent that Plaintiff’s allegations are inconsistent with the
article, this paragraph is denied.
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21.
The allegations in this paragraph purport to characterize websites by the Centers for
Disease Control and Prevention, the Department of Health and Human Services, the
World Health Organization, and the Washington State Department of Health, which
speak for themselves, and an article by WLNS.com, which speaks for itself. To the
extent that Plaintiff’s allegations are inconsistent with the websites and the article, this
paragraph is denied.
22.
The allegations in this paragraph consist of Plaintiff’s characterization of alleged
“questions” raised by unnamed individuals about which Defendant lacks knowledge or
information sufficient to form a belief about the truth of the allegations. Furthermore,
this paragraph consists of Plaintiff’s characterization of itself and its work about which
Defendant lacks knowledge or information sufficient to form a belief about the truth of
the allegations.
23.
Admitted that a group of individuals filed a Citizen Petition with FDA on June 1, 2021,
concerning Pfizer’s COVID-19 vaccine. The remaining allegations in this paragraph
purport to characterize a Citizen Petition submitted to FDA and a blog post, which speak
for themselves. To the extent that Plaintiff’s allegations are inconsistent with the Citizen
Petition and the blog post, those allegations are denied.
24.
The allegations in this paragraph purport to characterize three blog posts and one news
article from STAT, which speak for themselves. To the extent that Plaintiff’s
allegations are inconsistent with the blog posts and the article, this paragraph is denied.
25.
The allegations in this paragraph purport to characterize a blog post, which speaks for
itself. To the extent that Plaintiff’s allegations are inconsistent with the blog post, this
paragraph is denied.
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26.
The allegations in this paragraph purport to characterize a biographical website, an FDA
website, and a Wall Street Journal article, which speak for themselves. To the extent
that Plaintiff’s allegations are inconsistent with the websites and the article, this
paragraph is denied.
27.
Denied that “FDA did not convene its advisory group, VRBPAC, to have a public
meeting prior to licensure” and that “those interested were denied the opportunity to
both hear discussion about the data and to offer public comment about the same.” By
way of further response, Defendant avers that the VRBPAC Advisory Committee held
a public meeting on December 10, 2020, to discuss Emergency Use Authorization
(EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in
individuals 16 years of age and older. Furthermore, the allegations in this paragraph
purport to characterize a letter from several senators to then-FDA Commissioner
Stephen Hahn dated September 14, 2020, and an article by the Washington Times,
which speak for themselves. To the extent that Plaintiff’s allegations are inconsistent
with the letter and the article, this paragraph is denied.
28.
The allegations in this paragraph purport to characterize articles by the National Law
Review, Associated Press, Forbes, CNN, Yahoo! News, CNBC, CBS, ABC News,
KPBS, Reuters, The Hill, University Business, NBC News, NPR, Patch, NBC New
York, nj.com, Mercury News, The New York Times, Boston Herald, Mississippi Free
Press, Huffington Post, The Advocate, and the Los Angeles Times, as well as websites
by the White House, New York City, CVS, the University of Colorado—Boulder, the
University of California—Berkeley, Harvard University, George Mason University, the
University of Pittsburgh, New York State, California Department of Public Health, and
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City of Denver, which speak for themselves. To the extent that Plaintiff’s allegations
are inconsistent with the articles, this paragraph is denied. In addition, the paragraph
consists of Plaintiff’s characterization of alleged “objections” raised by unnamed
individuals about which Defendant lacks knowledge or information sufficient to form a
belief about the truth of the allegations.
29.
The allegations in this paragraph purport to characterize a bill, an article by The Hill, a
White House website, and an article by CNN, which speak for themselves. To the extent
that Plaintiff’s allegations are inconsistent with the bill, articles, and website, this
paragraph is denied.
30.
The allegations in this paragraph purport to characterize two New York state senate bills
and articles by nj.com and eastcountytoday.com, which speak for themselves. To the
extent that Plaintiff’s allegations are inconsistent with the bills and articles, this
paragraph is denied.
31.
The allegations in this paragraph purport to characterize articles from USA Today,
MSN.com, The New York Times, and Yahoo! News, which speak for themselves. To
the extent that Plaintiff’s allegations are inconsistent with the articles, this paragraph is
denied.
32.
The allegations in this paragraph purport to characterize an article by NBC News and a
video on YouTube, which speak for themselves. To the extent that Plaintiff’s
allegations are inconsistent with the article and video, this paragraph is denied.
33.
Admitted that Plaintiff submitted a FOIA request to FDA on August 27, 2021. The
remaining allegations in the first sentence of this paragraph consist of Plaintiff’s
characterization of itself and its work. Defendant lacks knowledge or information
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sufficient to form a belief about the truth of the remaining allegations in the first
sentence of this paragraph. Furthermore, an allegation in the first sentence of this
paragraph purports to characterize an FDA website, which speaks for itself. To the
extent that Plaintiff’s allegations are inconsistent with the website, this allegation in the
first sentence of this paragraph is denied. By way of further response, FDA avers that
it is committed to transparency while appropriately protecting confidential information.
Defendant admits the second sentence of this paragraph and avers that footnotes 41 and
42 of Plaintiff’s Complaint are copied verbatim from footnotes 1 and 2 of Plaintiff’s
FOIA request. Defendant respectfully refers the Court to the FOIA request dated
August 27, 2021, for a full and accurate statement of its contents. See Compl. Exh. A.1.
34.
The allegations in this paragraph purport to characterize a FOIA Request Confirmation,
which speaks for itself. To the extent that Plaintiff’s allegations are inconsistent with
the FOIA Request Confirmation, this paragraph is denied. Defendant respectfully refers
the Court to the FOIA Request Confirmation from FDA to Plaintiff dated August 27,
2021, for a full and accurate statement of its contents. See Compl. Exh. A.2.
35.
Admitted. Defendant respectfully refers the Court to the letter from FDA to Plaintiff
dated August 31, 2021, for a full and accurate statement of its contents. See Compl.
Exh. A.3.
36.
Admitted. Defendant respectfully refers the Court to the FOIA request dated August
27, 2021, for a full and accurate statement of its contents. See Compl. Exh. A.1.
37.
Admitted that FDA denied Plaintiff’s request for expedited processing on September 9,
2021. The rest of the allegations in this paragraph contain conclusions of law, to which
no response is required, or purport to characterize FDA’s letter to Plaintiff, which speaks
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for itself. Defendant respectfully refers the Court to FDA’s letter dated September 9,
2021, for a full and accurate statement of its contents. See Compl. Exh. A.4. To the
extent that Plaintiff’s allegations are inconsistent with FDA’s letter dated September 9,
2021, this paragraph is denied.
38.
This paragraph sets forth Plaintiff’s conclusions of law, to which no response is
required. The allegations in this paragraph also purport to characterize a statute, which
speaks for itself. To the extent that a response is required, FDA denies the allegations
in this paragraph.
39.
Admitted that Plaintiff stated in its FOIA request that it was “primarily engaged in
disseminating information” and that Plaintiff stated in its FOIA request there is an
“urgency to inform the public concerning actual or alleged Federal Government
activity.” The rest of the allegations in the first sentence of this paragraph are Plaintiff’s
characterization of its FOIA request, to which no response is required. Defendant
respectfully refers the Court to the FOIA request dated August 27, 2021, for a full and
accurate statement of its contents. See Compl. Exh. A.1. To the extent that Plaintiff’s
allegations are inconsistent with the FOIA request, the first sentence of this paragraph
is denied. As for the second sentence of this paragraph, admitted that FDA stated in its
letter to Plaintiff dated September 9, 2021, that Plaintiff had not “demonstrated a
compelling need that involves an imminent threat to the life or physical safety of an
individual” and that Plaintiff had not demonstrated that “there exists an urgency to
inform the public concerning actual or alleged Federal Government activity.” The rest
of the allegations in the second sentence of this paragraph are Plaintiff’s characterization
of FDA’s letter to Plaintiff, to which no response is required. Defendant respectfully
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refers the Court to FDA’s letter dated September 9, 2021, for a full and accurate
statement of its contents. See Compl. Exh. A.4. To the extent that Plaintiff’s allegations
are inconsistent with FDA’s letter dated September 9, 2021, the second sentence of this
paragraph is denied. The third sentence of this paragraph consists of Plaintiff’s
characterization of this action, to which no response is required. To the extent a
response is required, the allegations are denied.
40.
The first sentence of this paragraph consists of Plaintiff’s characterization of this action,
to which no response is required. To the extent a response is required, the allegations
are denied. The second, third, fourth, and fifth sentences of this paragraph consist of
Plaintiff’s characterization of itself and its work. Defendant lacks knowledge or
information sufficient to form a belief about the truth of the allegations in the second,
third, fourth, and fifth sentences of this paragraph. Furthermore, the fifth sentence of
this paragraph purports to characterize articles from Fox News, The BMJ, the Wall
Street Journal, The Federalist, and ArcDigital, blog posts on The BMJ and Re-Check,
and websites by Andrew Bostom, which speak for themselves. To the extent that
Plaintiff’s allegations are inconsistent with the articles, the fifth sentence of this
paragraph is denied. The sixth sentence of this paragraph consists of Plaintiff’s
characterization of this action and conclusions of law, to which no response is required.
To the extent a response is required, the allegations are denied.
41.
This paragraph sets forth Plaintiff’s conclusions of law, to which no response is
required. To the extent a response is required, the allegations are denied. Furthermore,
the allegations in this paragraph purport to characterize a judicial opinion, which speaks
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for itself. To the extent that Plaintiff’s allegations are inconsistent with the judicial
opinion, this paragraph is denied.
42.
The first sentence of this paragraph consists of Plaintiff’s characterization of this action,
to which no response is required. To the extent a response is required, the allegations
are denied. The second and third sentences of this paragraph consist of Plaintiffs’
characterization of a regulation, which speaks for itself. To the extent that Plaintiff’s
allegations are inconsistent with the regulation, the second and third sentences of this
paragraph are denied. The fourth sentence of this paragraph consists of conclusions of
law, to which no response is required. To the extent a response is required, the
allegations are denied.
43.
This paragraph consists of Plaintiff’s conclusions of law, to which no response is
required. Furthermore, this paragraph purports to characterize FDA websites, a statute,
and a regulation, which speak for themselves. To the extent that Plaintiff’s allegations
are inconsistent with the website, statute, and regulation, this paragraph is denied. By
way of further response, FDA avers that it is committed to transparency while
appropriately protecting confidential information.
44.
This paragraph consists of Plaintiff’s characterization of this action and conclusions of
law, to which no response is required. To the extent a response is required, the
allegations are denied. By way of further response, FDA avers that it is committed to
transparency while appropriately protecting confidential information.
45.
This paragraph consists of Plaintiff’s characterization of this action and conclusions of
law, to which no response is required. To the extent a response is required, the
allegations are denied.
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46.
The allegations in this paragraph consist of Plaintiff’s characterization of alleged
“declar[ations]” and “questions” raised by unnamed individuals about which Defendant
lacks knowledge or information sufficient to form a belief about the truth of the
allegations. This paragraph also consists of Plaintiff’s characterization of itself and its
work about which Defendant lacks knowledge or information sufficient to form a belief
about the truth of the allegations.
47.
This paragraph consists of Plaintiff’s speculation and characterization of this action, to
which no response is required. To the extent a response is required, the allegations are
denied.
48.
This paragraph consists of Plaintiff’s speculation and characterization of this action, to
which no response is required. To the extent a response is required, the allegations are
denied.
49.
This paragraph consists of Plaintiff’s characterization of this action, to which no
response is required. To the extent a response is required, the allegations are denied.
The paragraph also consists of Plaintiff’s characterization of alleged “objections” raised
by unnamed individuals about which Defendant lacks knowledge or information
sufficient to form a belief about the truth of the allegations. Furthermore, the allegations
in this paragraph purport to characterize articles by the National Law Review,
Associated Press, Forbes, CNN, Yahoo! News, CNBC, CBS, ABC News, KPBS,
Reuters, The Hill, University Business, NBC News, NPR, Patch, NBC New York,
nj.com, Mercury News, The New York Times, Boston Herald, Mississippi Free Press,
Huffington Post, The Advocate, and the Los Angeles Times, as well as websites by the
White House, New York City, CVS, the University of Colorado—Boulder, the
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University of California—Berkeley, Harvard University, George Mason University, the
University of Pittsburgh, New York State, California Department of Public Health, and
City of Denver, which speak for themselves. To the extent that Plaintiff’s allegations
are inconsistent with the articles and websites, this paragraph is denied.
50.
This paragraph consists of Plaintiff’s characterization of this action and conclusions of
law, to which no response is required. To the extent a response is required, the
allegations are denied. Furthermore, the allegations in this paragraph purport to
characterize a website by the White House and an article by CNN, which speak for
themselves. To the extent that Plaintiff’s allegations are inconsistent with the website
and article, this paragraph is denied.
51.
This paragraph consists of Plaintiff’s characterization of itself, its work, and its future
actions. Defendant lacks knowledge or information sufficient to form a belief about the
truth of the allegations in this paragraph.
52.
This paragraph consists of Plaintiff’s characterization of this action and conclusions of
law, to which no response is required. To the extent a response is required, the
allegations are denied. By way of further response, FDA avers that it is committed to
transparency while appropriately protecting confidential information.
53.
This paragraph consists of Plaintiff’s conclusions of law, to which no response is
required. To the extent a response is required, the allegations are denied. This
paragraph also purports to characterize a statute, which speaks for itself. To the extent
that Plaintiff’s allegations are inconsistent with the statute, this paragraph is denied.
The remaining paragraphs of the Complaint contain Plaintiff’s requested relief, to which
no response is required. To the extent a response is required, Defendant denies the allegations
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contained in the remaining paragraphs of the Complaint and further avers that Plaintiff is not
entitled to any relief.
Defendant hereby denies all allegations in the Complaint not expressly admitted or denied.
DEFENSES
1. Some or all of the requested records or information may be exempt from disclosure,
in whole or in part, under 5 U.S.C. § 552(b).
2. Plaintiff’s FOIA request is improper to the extent it does not reasonably describe the
records requested. 5 U.S.C. § 552(a)(3)(A).

Dated: October 18, 2021

Respectfully submitted,

BRIAN M. BOYNTON

Acting Assistant Attorney General

Civil Division

ELIZABETH J. SHAPIRO

Deputy Director

Federal Programs Branch

/s/ Courtney D. Enlow

COURTNEY D. ENLOW
Trial Attorney
United States Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W.
Room 12102
Washington, D.C. 20005
Tel: (202) 616-8467
Email: courtney.d.enlow@usdoj.gov

Counsel for Defendant

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CERTIFICATE OF SERVICE

I hereby certify that on October 18, 2021, I electronically transmitted the foregoing to the
parties and the clerk of court for the United States District Court for the Northern District of Texas
using the CM/ECF filing system.

/s/ Courtney D. Enlow

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FDA's answer to complaint — PHMPT v. FDA

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