Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
June 22 — The FDA must produce a list of the documents it's withholding on access to the experimental Ebola drug ZMapp so a federal district court can decide whether any of them should be released ( Goldwater Inst. v. HHS, D. Ariz., No. 2:15-cv-01055-SRB, 6/16/16 ).
The court's June 16 ruling comes at a time of increased interest in the access to experimental drugs for use in both pandemics and to aid the dying.
The Goldwater Institute filed litigation in the U.S. District Court for the District of Arizona asking the court to require the Food and Drug Administration to produce documents described in the institute's Freedom of Information Act request.
According to the Goldwater Institute, it is seeking the documents to better understand the internal decision-making process the FDA used to allow two American aid workers who contracted Ebola in Liberia access to ZMapp, which is still under safety review (8 LSLR 824, 8/22/14).
Starlee Coleman, vice president for communications for the institute, a Phoenix-based conservative advocacy group, told Bloomberg BNA in a June 21 e-mail that in the court's ruling, the “judge handed us a partial victory by ordering the government to produce a detailed log of all the records it would not provide to us so that the court may examine which ones must be released.”
The Goldwater Institute filed its FOIA request for documents on ZMapp on Aug. 7, 2014, saying that “every sick American should be treated the same” by the government (8 LSLR 1015, 10/17/14).
The institute is a leading advocate for “right to try” laws, which give terminally ill patients access to investigational medicines. At least 28 states have enacted such laws, most recently South Carolina in June (10 LSLR 12, 6/10/16).
Two days before the institute filed its FOIA request concerning ZMapp, a panel of the World Health Organization concluded that it's ethical to administer an unapproved intervention to treat the latest Ebola outbreak when no proven treatment exists (8 LSLR 844, 8/22/14). The WHO also called for convening a panel of medical authorities “to consider whether experimental drugs should be more widely released.”
The WHO announcement was prompted partly by concerns that those whom the FDA allowed to receive ZMapp were Americans while the Ebola epidemic was predominantly situated in West Africa.
ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies. Its components were developed at the Public Health Agency of Canada's National Microbiology Laboratory and at the U.S. Army Medical Research Institute of Infectious Diseases. It is undergoing further development under license by Mapp Biopharmaceutical.
Coleman told Bloomberg BNA, “The Goldwater Institute wants to know if the treating physicians for [those who received ZMapp] were required to comply with the FDA’s standard ‘compassionate use' process and procedures that other Americans seeking access to experimental medications must follow. If not, we simply want to know how other sick or dying Americans can also get an exception to the FDA process.”
According to court records, the FDA denied the institute's FOIA request due to concerns about the aid workers' privacy and the potential release of information about trade secrets. “Because the FDA has refused to hand over records, we were forced to file an actual lawsuit so that we can review these public documents,” Coleman said.
In the litigation, both parties moved for summary judgment, with the FDA contending that it hadn't improperly withheld any records in response to the FOIA request and the institute arguing that the FDA wrongfully withheld public records.
In the court's order, Judge Susan R. Bolton wrote that the court couldn't determine whether the FDA’s assertion that trade secrets and confidential commercial information are “inextricably intertwined” in the documents is by itself sufficient to meet its burden to show that the documents are covered by the trade secret exception to the FOIA.
The court also was uncertain whether any of the documents met the private information exception, Bolton wrote.
However, because the Goldwater Institute expressly requested documents reflecting the FDA’s “deliberations made during [the authorization] process,” the court concluded that the FDA had lawfully withheld at least some documents under the deliberative process exception.
The court agreed with the institute's argument that the FDA should provide the court with a Vaughn Index, which is a document that agencies prepare in FOIA litigation to justify each withholding of information under an exception.
“Defendant has not provided a meaningful explanation for why a Vaughn index was not supplied or for why it would not prove beneficial in this case,” Bolton wrote.
Once the Vaughn index is received, Bolton said, the court will order additional summary judgment briefing if the institute isn't satisfied that the exemptions apply.
To contact the reporter on this story: John T. Aquino in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at email@example.com
The court's order is at http://src.bna.com/f82.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)