FDA Patient Network Launches New Website

The FDA’s new Patient Network website gives patients and advocates a bigger voice in medical product regulation, which includes drugs, devices and biologics. Designed as a key education and communication tool between the FDA and the public, the site features patient-friendly information on drug and device development and approval, clinical trials, latest treatment options, important safety information and more. It also connects members of the public to the Patient Representative Program, where they can apply to sit on official FDA Advisory Committees and act as consultants during the drug and device review processes. For more information, visit the FDA Patient Network website.

Get Informed. Get Involved. Help FDA Help Patients Have a Bigger Voice.  That’s the slogan of a new FDA web site that I’m excited to announce today. The FDA Patient Network has been designed from the ground up to focus entirely on patients.

FDA has long been developing ways to increase patients’ interest and participation in the agency’s work, and in the policies and decisions that affect them.

Since the early 1990s, FDA has been working directly with patients and patient advocates to help them learn more about how medical products are developed and regulated. Patient representatives participate in FDA advisory meetings, and contribute the important perspective of their patient community. When patients better understand the intricacies of how medical products are studied, reviewed, assessed and brought to market, their input will be that much more focused and valuable. We hope, with the launch of this new web site, to expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways.

The FDA Patient Network web site is an interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­–and medical devices move from the realm of idea to the realm of the marketplace. It brings together, in one place, information that is important to patients, making it easier for them to find what they are looking for and to understand the significance of their findings.

This web site will open new channels of communication with the public, such as live chats with senior agency officials. It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.

I am excited because this new Patient Network web site provides a new model for FDA to follow in making its inner workings transparent to the public. It ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities. I encourage you to explore the new site at PatientNetwork.FDA.gov.

FDA Approves Shift in Labeling for Certain Prescription Medications

Controversy abounds when prescription medication is the topic. In mid-April, the U.S. Food and Drug Administration (FDA) gave notice that it was updating the label for a hydrochloride medication, commonly known as OxyContin. In an explicit warning, the new packaging will alert users to the new properties of the drug in hopes of preventing abuse.

Citing prescription overdose as a public health epidemic, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said, “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” and although “both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

Some of the issues relating to prescription medication abuse caused the FDA to release the following analysis.

• Citizen petitions requesting that the agency determine whether original OxyContin was voluntarily withdrawn from sale for reasons other than safety or effectiveness
• Information concerning original and reformulated OxyContin and the withdrawal of original OxyContin
• Clinical data, peer-reviewed literature, and other information concerning postmarketing adverse events associated with original OxyContin, reformulated OxyContin, and other extended-release oxycodone products
• Postmarketing assessments of the impact of reformulated OxyContin on abuse are ongoing, and the FDA will update its evaluation of the effects of reformulated OxyContin on abuse as new data become available.

Ultimately, the FDA said, its goal is to both “encourage the development of abuse-deterrent formulations of opioids” and to “help reduce prescription drug abuse.” The Agency was firm in its commitment to providing patients with pain relieving medications that are appropriate and safe. Find out more about this labeling notification.