Health Law Advisor Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Tag Archives: FDA

FDA Adopts New Designation Process for Regenerative Advanced Therapies

On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act.  Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.

The accelerated approval provisions for RATs under the 21st Century Cures Act are intended to facilitate expedited … Continue Reading

Congress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts?

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the rulemaking process. Both bills passed the House on party-line votes, and are under consideration by the Senate.

The first bill, H.R. 5, would overhaul multiple phases of the federal rulemaking process. These proposed changes would make the rulemaking process significantly longer and more complex for … Continue Reading

FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product’s approval. FDA’s guidance documents issued this week also clarify some grey areas surrounding the circumstances under which manufacturers may communicate about information that is consistent with or … Continue Reading

Stakeholder Agendas in the Washington Transition: 5 Takeaways for Converting Ideas into Technically Effective Proposals

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

But whatever policies a stakeholder advocates, ideas must be translated into a … Continue Reading

New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called “superbugs,” estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the same study projected 8.2 million deaths from cancer, and 1.2 million deaths from traffic … Continue Reading

Parallel Review – Forcing Manufacturers to Go All In

On October 24, 2016 the Food and Drug Administration (“FDA”) in conjunction with the Centers for Medicare & Medicaid Services (“CMS”) announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope and involves significant risks for manufacturers.

The standard process for obtaining … Continue Reading

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, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is … Continue Reading

New FDA Draft Guidance Shows Limited Compromise with Brand and Generic Drug Manufacturers

The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information.  The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a “Withdrawn RLD”).  The Draft Guidance explains how a generic manufacturer may submit an updated label of a generic drug to the FDA for approval after withdrawal … Continue Reading

“Good Faith” Off-Label Promotions Saved Ex-Acclarent Execs from Felony Misbranding Indictments

Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent’s device, the Relieva Stratus Microflow Spacer (“Stratus”), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant’s request to expand the indicated use of the device to include delivery of drugs, the government alleged that Acclarent promoted … Continue Reading

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 biologics manufacturers with the ability to update safety information on their labels independently … Continue Reading

The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals

Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs.  More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”).  In its announcement, HHS stated that the revisions will be focused on defining and clarifying “the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements.”  The announcement also notes that the changes will “better protect the rights, safety … Continue Reading

Will Sad Facts Make Bad Law?

Despite popular opinion, lawyers and judges are human and sometimes the facts of a case make it near impossible for judges to play the role of the modest umpire calling balls and strikes described by Chief Justice Roberts in his confirmation hearing.  Sometimes, bad facts make bad law because the plaintiff is so sympathetic that the just ruling may not be the “right” one.  Fachon v. U.S. Food and Drug Administration et al., appears to be the epitome of this.

Earlier this year, a 20-year old man, Eugene Neil Fachon, was diagnosed with Diffuse Intrinsic Pontine Glioma (“DIPG”) a … Continue Reading

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 Investigational New Drug Application or Investigational Device Exemption.

While the recommendations set forth in the Draft Guidance do not … Continue Reading

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 have the potential of harming patients. Manufacturers have argued that new and emerging technologies will help avoid these … Continue Reading

FDA Leverages Patient-Reported Information to Monitor Drug Safety

FDA has recently partnered with PatientsLikeMe, an online patient networking forum, to leverage patient-reported information to bolster its drug safety monitoring efforts. PatientsLikeMe, with its 350,000 members representing over 2,500 health conditions, has collected more than 110,000 adverse event reports on 1,000 different drugs. This partnership, which is in the form of a research collaboration agreement, will provide FDA with access to “real-world” data about patients’ drug and disease experiences (the information provided to FDA is anonymous; so it does not appear, at least at this time, that FDA would be able to follow up with patients who post … Continue Reading

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

Our colleagues James A. Boiani and John S. Linehan at Epstein Becker Green wrote an advisory on the U.S. Food and Drug Administration’s (“FDA”) introduction of new plans to constrain animal drug compounding with the release of its Draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances. In this advisory, the parameters of the Draft Guidance are outlined, which suggests that a dramatic shift in the FDA’s enforcement approach may be underway and provides insight into the FDA’s enforcement priorities and its interpretation of the applicable regulatory regime.

Read the full alert online.Continue Reading

3-D Printing Guidance Only a B-List Priority for FDA

While FDA made a push last fall to explore the technical challenges associated with 3-D printed devices (holding a public workshop in October 2014), the Agency’s planned guidance on the topic fell to the “B-list” in FDA’s 2015 medical device guidance agenda. According to the agenda, the Agency will issue a draft guidance document on 3-D printing as “guidance-development resources permit.” In light of the regulatory uncertainty facing 3-D printing stakeholders, this may seem like unwelcome news – but is it?

Recent comments from Agency officials suggest that immediate guidance is unnecessary because 3-D printing, despite prior comments, is … Continue Reading

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.  stethescope

For example, the Oncologic Drugs Advisory Committee (“ODAC”) hearing, earlier this month, was not only historic because ODAC unanimously recommended FDA approve the first biosimilar product under … Continue Reading

Complimentary Webinar – Wireless Health Regulatory Issues: A 2015 Roadmap to FDA, FCC, and Privacy and Cyber Security Issues

WHEN: Thursday, February 26, 2015

TIME: 12:00pm – 1:30pm EST

To register for this webinar, please click here.

Please join us for a complimentary webinar addressing wireless health regulatory issues. This session will discuss recent trends in health technology regulation; including Food and Drug Administration (FDA) developments, Federal Communications Commission (FCC) requirements, wireless technology and communication issues, mobile applications, decision support and other Health IT challenges, and privacy and cyber security considerations.

This session is relevant to tech companies, communications companies, entrepreneurs, and developers that are entering the wireless health technologies space or considering acquiring mobile health assets.

Topics Continue Reading

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 going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies … Continue Reading

FDA Continues Its De-Regulatory Trend with the Release of the Wellness Guidance

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low risk” and are intended to:

  1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
  2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy lifestyle may reduce the risk
Continue Reading

The Rise of the Online Package Insert?

On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging.  FDA’s stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available.  The proposed rules also go against Senate Appropriations Committee directions to FDA to “ensure that any proposed regulation regarding electronic inserts does not come … Continue Reading

FDA’s Wholesale Distributor and 3PL Reporting Requirements Draft Guidance Provides Some Clarity Not Found in Previous Draft Guidance

FDA is the subject of a lot of criticism, some deserved, and some not.  However, I don’t think FDA gets enough praise when it does something right.  Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.

Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA.  This clarification likely has the … Continue Reading

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 by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to Congress … Continue Reading