Feds Try Harder to Make Manufacturers Test Drugs for Use by Children

by Patrick Malone & Associates P.C. | DC Injury Lawyers

Children are not miniature adults, and drugs intended to be consumed by adults aren’t necessarily good medicine for kids. A blog post on the FDA Voice website explains why.

Lynne Yao, associate director, Pediatric and Maternal Health Staff in the FDA’s Center for Drug Evaluation and Research, reminds readers that some drugs work differently according to where in the human maturation the person taking them is. Efficacy is one issue for children taking drugs intended for adults, and safety is another. “That’s why products that are used in children,” Yao says, “must be studied in children."

Two recently reauthorized laws promote that effort. The carrot is the Best Pharmaceuticals for Children Act (BPCA), which offers drug companies six months more of marketing exclusivity if they conduct FDA-requested pediatric studies. The stick is the Pediatric Research Equity Act (PREA), which requires some drugs developed for adults to be studied in children. The studies must be conducted with the same drug and for the same use for which they were approved in adults.

As Yao notes, before BPCA and PREA became law, more than 8 in 10 drugs approved for adult use were being used in children, even though their safety and effectiveness had not been established in children. Today, it’s about 5 in 10. And now that both acts have been reauthorized with additional FDA powers, the hope is that the disparity will shrink farther.

Under PREA, FDA may waive studies in children if they aren’t necessary, such as a drug prescribed for a disease only adults contract, like prostate cancer.

When Congress reauthorized PREA last year as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), it gave the FDA additional authority. The agency may grant extensions for deferred pediatric studies at a sponsor’s request if there is good cause; say, the manufacturer has tried but failed (so far) to recruit a sufficient number of pediatric patients to complete the study.

Sometimes the FDA allowed a deferral and still the deadline was missed, so now, if a sponsor fails to seek or obtain a deferral extension, fails to submit deferred pediatric studies by the final due date agreed to with FDA or fails to request approval for a required pediatric formulation, the FDA will send a noncompliance letter to the company and publish it on the web.

The first such “we warned you” noncompliance letters were published last month, along with the manufacturers’ responses. You can track this show-and-tell at the FDA’s public page here. Among the early letters and responses are those concerning an intravenous form of Protonix, a drug to reduce gastric acid made by Pfizer, and Renvela, taken by people with chronic kidney disease, made by Sanofi.

Other drugs on the tardy-testing list include allergy, anaphylaxis and blood pressure medications, all of which are prescribed for children.

As noted on AboutLawsuits.com, however, it’s unclear whether these laws and the transparency of noncompliance give the FDA enough muscle to compel compliance.

The letters state that the companies failed to satisfy their obligations to conduct pediatric studies on approved children’s medications, but as AboutLawsuits points out, the FDA may label a drug misbranded only if the studies are not conducted. It may not withdraw approval. It’s unclear if the agency can levy fines or take any other punitive actions beyond the public scolding.

Some of the drugs on the letter list were supposed to have been tested on children as long as seven years ago. In each case, AboutLawsuits says, the companies failed to apply for an extension. Although the letters give the companies 45 days to respond, they are silent about any consequences or what happens next.

The FDA’s renewed interest in the safety of pediatric drugs follows recent studies depicting how some medications used on adults have detrimental effects in children.

For example, a study published last month in JAMA Psychiatry found that children who use antipsychotic medications such as Risperdal and Zyprexa had three times the risk of developing type 2 diabetes during the first year of use. That study was the result of a government investigation into the increasing number of children who were prescribed antipsychotic medications intended for adults.

If your child is prescribed a medication, ask the doctor if it has been tested in that form and in that dose for children. If not, or if he or she doesn’t know, consult Medline Plus, the government’s drug information clearing house, and the manufacturer’s website.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Patrick Malone & Associates P.C. | DC Injury Lawyers | Attorney Advertising

Written by:

Patrick Malone & Associates P.C. | DC Injury Lawyers

Patrick Malone & Associates P.C. | DC Injury Lawyers on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.