Food and Drug Administration (FDA)

Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year. We cover this and more in this week’s health care preview, which you can find by clicking here.

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018. As a follow up to its milestone gene therapy product approvals in 2017 (see here and here), FDA had promised to develop gene therapy-specific guidelines to help spur innovation in this area by providing industry with useful advice and greater regulatory clarity. However, it’s fair to say that we were not expecting to see this large of a transparency commitment by the Agency, which concurrently issued six new guidance documents. FDA Commissioner Scott Gottlieb also issued a lengthy same-day statement on the Agency’s “efforts to advance development of gene therapies,” in which he stated in part: Continue Reading FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018

This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week. On the Administration’s side, several agencies took steps forward consistent with the President’s agenda on drug pricing. How this plays out over the next several months will be relevant to all stakeholders in this space. We cover this and more in this week’s preview, which can be found here.

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs.

The speech made pointed attacks on “the middlemen” and drug lobbyists. President Trump even called out Secretary Azar’s past role as a drug company executive when calling out drug companies’ role in high drug prices. Continue Reading President Trump Delivers Much Anticipated Drug Pricing Speech

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance

This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after the President’s speech on drug pricing was postponed. Both committees of jurisdiction in the House and Senate are moving on opioid legislation this week, so that has our immediate attention. The speech delay offers a momentary reprieve for stakeholders, but there’s still a Request for Information of some kind pending at the Office of Management and Budget, so it is likely that there will be action in this eventually.

Additionally, on our radar are new Democratic proposals around expansion of health coverage as well as the Administration’s potential action regarding ACA nondiscrimination protections. We cover this and more in this week’s health care preview, which you can find here.

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33 of the device Warning Letters in 2017 were issued for cGMP, Quality System, or MDR violations, a remarkable figure since FDA regularly sent over 100 device regulation compliance Warning Letters every year from 2011 to 2015.

One might expect that fewer Warning Letters means fewer inspections, but FDA’s inspection database shows that the number of device compliance inspections has remained fairly consistent from 2011 through 2017. The number of inspections has certainly decreased from a high of 1,859 in 2011, but FDA conducted 1,624 device compliance inspections in 2014, 1,533 in 2015, 1,539 in 2016, and 1,551 in 2017. Clearly, the sudden drop off in Warning Letters has been much steeper than the modest decrease in inspections.

What could be driving this decrease in Warning Letters? I briefly explore three possibilities below. Continue Reading Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention. The Administration is also going to take another look at drug pricing which is setting the stage for another busy work period. We cover this and more in this week’s preview, which you can find here.

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers.

The OIG’s most recent study focuses on dispensers of various sizes and types, including independent retail pharmacies, chain retail pharmacies, and small and large hospital pharmacies. Of the 40 dispensers interviewed, the agency found that all them had received at least some drug product tracing information from their trading partners, and 26 of these dispensers received all required elements of this information. The remaining 14 dispensers were missing a few of the required elements. Two of the dispensers were unaware of the DSCSA. The following table summarizes the missing information:

The OIG also found that dispensers received drug product tracing information in a variety of transmission modes and formats. The agency believes this is a result of dispensers and their trading partners using different systems rather than adopting a standardized way to exchange this information. Neither the DSCSA nor FDA guidance requires a uniform transmission mode or format for the exchange of drug product tracing information.

To facilitate dispensers’ compliance with the DSCSA, the OIG recommends that FDA offer educational outreach to dispensers where appropriate. Specifically, the agency recommends that FDA provide education to ensure that dispensers understand their responsibilities to receive complete drug product tracing information from trading partners before taking ownership of drug products.

For its part, FDA concurred with the OIG’s recommendation and intends to review its dispenser communications plan and identify and create opportunities to work with dispenser-centric trade and professional organizations to provide additional education and outreach. FDA also noted in its response that, as the last trading partner in the supply chain before a drug product is dispensed to a patient, dispensers play a vital role in ensuring patient safety, making it essential that they understand their product tracing responsibilities under DSCSA.

We will continue to monitor and report on the industry’s implementation of the DSCSA, including the OIG’s planned study of the extent to which drug product tracing information can be used to trace drugs through the entire supply chain.