Recent Blog Posts
- FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board? On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.
In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders,... More
- FDA Rule Providing Generic Manufacturers with the Ability to Unilaterally Update Safety Labels May be Abandoned On May 19th, the FDA again postponed publication of the Final Rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” to April 2017 (the “Final Rule”). On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making (“NPRM”) was originally published in November 2013 to provide generic drug and... More
- FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of Electronic Health Record (“EHR”) data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an... More
- FDA Releases Guidance to Assist the Development of Advanced Technology to Modernize Pharmaceutical Manufacturing On December 23, 2015, the Food and Drug Administration’s (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.
Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing patients access to drugs and... More
- Are Lower Cost Drugs Less Effective? It May Depend on the Patient’s Perspective. One of the most discussed aspects of healthcare has to be how to balance cost, quality and access. This is especially true when it comes to the pharmaceutical industry, particularly with the rapid growth of and increased focus on highly effective, but highly expensive, specialty drugs. Discussions about these costs are no longer isolated to negotiations between pharmaceutical companies, PBMs and insurers; instead it appears that price and cost are on FDA’s radar.
For example, the Oncologic Drugs Advisory Committee... More
- Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter? When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not... More
- FDA Launches Drug Trials Snapshot to Provide the Public with Information about the Clinical Trials Supporting New Drug Approvals Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014. This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.
The Drug Trials Snapshot website was developed... More
- Direct-to-Spouse Prescription Drug Advertisement On November 13, 2014, the Food and Drug Administration (“FDA”) announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements. FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made. For example, FDA notes that when spouses view an ad together a spouse “may influence their partner by expressing concern about risk and sides effects that might occur, or pressuring... More
- FDA Continues to Exercise Its Authority to Speed Access to Products That May Aid in the Prevention and Treatment of Ebola Infection On November 10, 2014, FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0, an in vitro diagnostic device for the detection of Ebola viruses. This is the most recent in a series of measures taken by FDA in recent months to facilitate rapid access to drugs, biologics and medical devices with potential benefits in the prevention, diagnosis or treatment of infections with the Ebola virus.
Emergency Use Authorization
Pursuant to Section 564 of the Food Drug & Cosmetic Act (21... More
- FDA’s Second Guidance on the Drug Supply Chain Security Act Misses the Mark
Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.
In November 2013, Congress enacted the Drug Supply Chain Security Act (“DSCSA”) with the intent of establishing a “Uniform National Policy” for wholesale distributor and third party logistics provider (“3PL”) licensure. Congress hoped to... More