The U.S. Department of Health and Human Services (HHS) is requesting comment on which temporary regulatory actions taken by its agencies as a result of COVID-19 should be made permanent once the pandemic is over.
In following an executive order that called on federal agencies to address the economic emergency caused by COVID-19 by rescinding, modifying, waiving or providing exemptions from regulations and other requirements that may inhibit economic recovery, HHS identified 382 regulatory actions its agencies have implemented in response to the pandemic.
All the actions were efforts to improve access to care and reduce costs during the public health emergency, according to a notice published in the Nov. 25 Federal Register. The notice includes a table of the actions taken. HHS is asking for comments, by Dec. 28, on which ones were beneficial or detrimental to providers and patients, as well as which ones were beneficial but would be detrimental if they were made permanent.
Among the regulatory actions up for review are FDA pandemic-driven guidances on distribution of drug samples, notification of a discontinuance or interruption in drug manufacturing, exemptions and exclusions from certain requirements of the Drug Supply Chain Security Act, postmarket adverse event reporting, institutional review board reviews of expanded access requests and conduct of clinical trials during the pandemic. The table also includes several actions related to NIH grants.
In addition, HHS announced that it is publishing a policy statement to enhance transparency throughout the department by “requiring that all assumptions, working papers, models and other information used as part of any impact analysis associated with a rule or demonstration project are shared at the time the results of that analysis are publicly disclosed.”
That notice is scheduled for publication in the Nov. 27 Federal Register.
The other shoe drops
The FDA is issuing an order permanently debarring Michael Babich, the former president and CEO of Insys Therapeutics Inc., from providing services in any capacity to anyone with an approved or pending drug application.
The debarment comes nearly two years after Babich pleaded guilty to one count of conspiracy to commit mail fraud and wire fraud and one count of mail fraud for his role in a conspiracy to bribe doctors to induce them to prescribe Insys’ fentanyl-based pain drug Subsys to patients even when medically unnecessary.
Babich, who testified against other Insys officials involved in the conspiracy, was sentenced to 30 months in prison, with three years of supervised release, and ordered to pay restitution and forfeiture. Although Babich entered his guilty plea in January 2019, he wasn’t sentenced until January 2020.
In other enforcement news, Purdue Pharma LP honored the terms of its October settlement with the Department of Justice when it pleaded guilty Nov. 24 to three felony counts of conspiring to defraud the U.S. and violate the anti-kickback statute in the promotion of its opioid products, including Oxycontin.
The plea agreement included a criminal fine of $3.5 billion plus $2 billion in criminal forfeiture, $225 million of which must be paid within three business days following the entry of a judgment of conviction. A separate civil settlement resolving False Claims Act violations gives the U.S an unsubordinated, general unsecured bankruptcy claim against Purdue of $2.8 billion.
The guilty plea came one week after a bankruptcy judge gave the private Stamford, Conn.-based company the go-ahead to enter the agreement.
Meanwhile in a separate incident, HHS reported that David Panka, a former Harvard Medical School instructor and former associate professor at Beth Israel Deaconess Medical Center, entered a voluntary settlement agreement to resolve findings of research misconduct involving research supported by the NIH.
According to a notice published in the Nov. 25 Federal Register, HHS found that Panka falsified or fabricated Western blot images by selectively cutting, flipping, reordering and reusing the same source images or noncorrelated images to represent different results in three published papers and a conference presentation.
As part of the settlement, Panka agreed to have his research supervised for three years and to request that the papers and conference abstract be corrected or retracted.
NICE gives nod to new myeloma regimen
The U.K.’s National Institute for Health and Care Excellence (NICE) said Nov. 24 that it’s recommending isatuximab (Sarclisa, Sanofi SA) plus pomalidomide (Pomalyst, Celgene Inc.) and dexamethasone as a fourth-line treatment option under the Cancer Drugs Fund (CDF) for treating relapsed and refractory multiple myeloma in adults.
The treatment can’t be recommended for routine use yet, because the cost-effectiveness estimates are uncertain given the limited data available, according to NICE. However, more data from an ongoing trial and real-world experience with the regimen through the CDF are expected to address those uncertainties.
“Some of the data our committee has already seen shows promise that isatuximab plus pomalidomide and dexamethasone delays the disease from progressing and increases how long people live compared with current treatment options,” said Meindert Boysen, deputy chief executive and director of NICE’s Centre for Health Technology Evaluation.
MHRA prepares for January
Readying the way for the end of the Brexit transition period, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance Nov. 24 on exporting active substances manufactured in Great Britain for use in Ireland and the European Economic Area (EEA) beginning Jan. 1.
The guidance explains how to obtain a written confirmation for each shipment of active substances to be exported to those areas.
The MHRA also confirmed that it will continue to accept imports of active drug substances into Great Britain without a written confirmation so long as the substances are coming from Australia, Brazil, the EEA, Israel, Japan, Northern Ireland, South Korea, Switzerland or the U.S.
FDA guidances finalized
The meeting guidance finalizes a draft issued in October 2017 describing the enhanced pathway for meetings between the FDA and sponsors who are preparing to submit, or already have submitted, an abbreviated new drug application for a complex generic drug.
The guidance defines the meeting types, advises on meeting requests and provides general information on how the agency assesses those requests, reschedules or cancels meetings, communicates with the sponsor prior to a meeting and conducts the meeting. It also discusses the content and submission of a meeting package.
Required by the 21st Century Cures Act, the guidance on qualifying drug development tools finalizes last year’s draft, providing additional clarity on the qualification process, support for the proposed time frames, and requested references to content element outlines for specific programs.