Welcome to The Weekly Review – a timely recap of AgencyIQ’s coverage of major life sciences regulatory trends and the biggest developments at FDA from the past week. It’s been an unsettling few days for much of the US as the realization dawns on many that things are about to become abnormal for a few months. During this uncertain time, we’ve been exploring how COVID-19 will affect FDA systems, processes, and regulatory approvals. We’ve also been covering profound developments related to the VALID Act, FDA’s new diabetes drug development guidance, and companies’ response to shifting drug importation policy. To gain full access to all of the coverage summarized here, contact us. Have tips or suggestions for what we should be covering? Contact Alec Gaffney at firstname.lastname@example.org
The Weekly Review
AgencyIQ and POLITICO have been closely following almost all aspects of the COVID story from a regulatory angle, including gaps in regulatory authority, changes at the FDA, play-by-plays of where government employees have erred and more. Our must-read from this week looks at how the FDA’s regulatory activities are set to change under the Coronavirus. A key issue: Will new product approvals be on hold if pre-approval inspections can’t take place?
The other major story this week that seems to have been overlooked by
most in Washington is the release of the new text of the VALID Act. The
legislation would fundamentally change how every IVD and LDT is regulated, and
would also have major implications for pharmaceutical and biological products
using companion diagnostics. It was a major story, and AgencyIQ has extensive
analysis on what the legislation is and what it would do.
We’re also happy to announce that the AgencyIQ’s research team has
recently grown. In additional to some familiar names (Lily Rosenfield and Laura
DiAngelo), we’re happy to announce the addition of Kedest Tadesse and Aaron
Badida. Kedest comes to us from the Weinberg Group and has a MS in
biotechnology and her RAC. Aaron comes to us from Advent Health and has a JD.
Expect to see their names and analysis often in the coming weeks.
We would also love your feedback on a new feature we’re starting to
roll out called Policy Position Summaries. This at-a-glance analysis
shows you what the industry has said about a particular regulatory proposal. You
can find our first one here (no paywall). Please let us know what you
think, and if we could add anything to make it even more useful.
We hope you all stay safe and healthy over the next few weeks. If cabin
fever starts to strike, you can always reach out to the AgencyIQ team with
regulatory questions, thoughts, concerns or tips.
REGULATORY HIGHLIGHT: VALID ACT
A bill proposed last week, known as the VALID Act, would establish a
new regulatory framework for diagnostic devices. It also would alter the way
that companion diagnostics are developed and cleared for market. As precision
medicine and pharmacogenomics are expected to increase as a share of the
pipeline, Laura DiAngelo discusses what drug manufacturers should know about
the potential changes.
Two years after last trying to update the way in which the FDA
regulates diagnostics, lawmakers have introduced a new bill that would create a
new framework. The bill, known as the VALID Act, would regulate both in vitro
diagnostics and laboratory-developed tests. Laura DiAngelo’s analysis breaks
down what you need to know.
LEADING THE WEEK: CORONAVIRUS HEATS UP
The Food and Drug Administration is suspending in-person meetings,
non-essential travel and many external meetings, according to agency
communications shared with AgencyIQ. Alec Gaffney highlights the potential
industry impacts from these changes.
Joanne Kenen, POLITICO healthcare editor, highlights how the Trump
administration’s decision to forgo a World Health Organization test and create
their own had fateful consequences, according to experts.
POLITICO’s Amanda Eisenberg reports that Northwell Health will begin
semi-automated testing for coronavirus today after the FDA approved emergency
use authorization late last night.
The FDA announced Tuesday it will postpone most foreign inspections of
medical products due to the coronavirus, effective immediately. David Lim
reports the agency will still consider conducting “mission-critical”
inspections on a case-by-case basis, according to FDA Commissioner Stephen
House Energy and Commerce leaders want a briefing from FDA Commissioner
Stephen Hahn on the agency’s efforts to stem potential drug and medical device
shortages linked to the coronavirus, Sarah Owermohle reports.
Sarah Owermohle reported Monday that the FDA and FTC issued warning
letters to seven companies for falsely claiming their products help fight the
coronavirus infection, dubbed Covid-19. The seven companies include makers of
essential oils, tea, tinctures and colloidal silver.
Dan Diamond brings us an exclusive look at a daylong IT snafu last
month which infuriated health officials, adding fuel to tensions among
department leaders. The outage in the Health and Human Services secretary’s
office stretched on much of Feb. 23, with some messages delayed up to 11 hours,
creating frustration and slowing the Trump administration’s coronavirus
THIS WEEK IN PHARMACEUTICAL REGULATION
Healthcare industry offers comments on FDA proposal to allow drug imports from Canada (Stakeholder Analysis)
In December 2019, the FDA proposed a plan to allow the importation of
eligible prescription drugs from Canada. This proposal is based on a plan that
would allow state governments to co-sponsor importation plans that could be
approved by the FDA. Public comments on the proposal closed March 9, 2020. The
FDA received more than 1,200 comments on the proposal. AgencyIQ’s Aaron Badida
has analyzed the comments of dozens of the healthcare industry’s most notable
Following years of debate, the FDA has formally withdrawn two existing
guidance documents that called for extensive—and expensive—studies to assess
the cardiovascular risks associated with diabetes drugs. Alec Gaffney’s
analysis shows the move follows the publication of several large studies which
did not substantiate the regulators’ original concerns.
Sarah Karlin-Smith notes the FDA announced in draft guidance it will no
longer require drug companies to conduct large cardiovascular safety studies
for all new type 2 diabetes therapies.
The House Energy and Commerce committee wants an FDA briefing on the
types of temporary drug market withdrawals that the agency receives and how it
tracks this information, due to concerns some of these withdrawals are related
to price-fixing schemes, Sarah Karlin-Smith reports.
THIS WEEK IN BIOLOGICS REGULATION
In an updated guidance analyzed by Laura DiAngelo, the FDA clarified
this week that blood establishments don’t need to report on some donor issues
that become apparent after a donation is already made in their biologic product
Sarah Karlin-Smith reports that experts convened at FDA headquarters
Monday morning to discuss ways that FDA and FTC can ensure biosimilars have a
fair shot at competing with pricey biologics. One looming question was whether
FTC should take antitrust action against brand-name manufacturers that attempt
to ward off biosimilar competition through misleading claims.
THIS WEEK IN MEDICAL DEVICE REGULATION
Manufacturers of certain well-understood low or moderate risk device
types could see streamlined reviews through the FDA’s third-party review
program. New guidance, finalized March 11, outlines the criteria by which
devices are eligible and organizations can be accredited, but, as Laura
DiAngelo discusses, it’s unclear how well the clarified requirements will
streamline the review process.
The FDA is recommending that sponsors of electrosurgical devices, used
during surgery to cut and cauterize tissue, test their devices to measure the
extent to which they could cause “thermal damage” to tissue surrounding a cut.
Laura DiAngelo’s analysis breaks down what you need to know.
WHITE OAK WATCH
The House Energy and Commerce Health Subcommittee will markup 13 bills
Wednesday, including many FDA-focused drug and device measures. Sarah
Karlin-Smith discusses what is on the agenda.
POLITICO’s Mona Zhang reported last week that the FDA reiterated its
commitment to collecting more data on CBD. The agency will reopen the public
docket for CBD comments “very soon,” a spokesperson said, declining
to commit to a specific date.