Recent Blog Posts
- Chicago Releases Draft Rules on Pharmaceutical Representative Licensure In a previous blog post, we discussed a City of Chicago Ordinance, set to take effect on July 1, 2017, that will require pharmaceutical sales representatives to obtain a license before being able to operate within city limits. The draft rules for this ordinance were released on March 17, 2017.
These rules provide additional detail regarding the licensure requirements as well as other associated education and disclosure requirements with which pharmaceutical representatives will be expected to comply beginning in July of... More
- The Future Impact of Populism on Drug Pricing Reform In 2016, the populist trend in American politics was an undeniable factor behind Trump’s election victory as well as the ascendancy of Bernie Sanders and Elizabeth Warren within the Democratic Party. During upcoming months, industry observers will be looking for signs as to whether drug pricing is an area in which both parties can agree on instituting significant legislative action at the state and federal levels. The nature and shape of any such reforms will be highly consequential for the... More
- Chicago Imposes Burdensome New Licensure and Disclosure Obligations on Pharmaceutical Representatives On November 16, the City of Chicago passed an ordinance that will require pharmaceutical sales representatives to become licensed in order to promote prescription drugs to health care providers within city limits. The ordinance was passed unanimously, despite ardent objections from pharmaceutical manufacturers and industry organizations. While Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction, industry representatives characterize the license as a harmful... More
- 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