Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Opening Statement of Rep. Pallone, Hearing on Examining Medical Product Manufacturer Communications

Hearing

Mr. Chairman, I want to thank you for holding today's hearing. The issue before us today is
an important one, and I hope that our discussion will help to inform whether or not it would
be appropriate for this Committee to take further action at this time.
Today, under current law, medical product manufacturers are required to demonstrate the
safety and effectiveness of each intended use of their medical product. This review process
has been critical to protecting and promoting public health by ensuring that the benefits of
medical products that are prescribed to patients outweigh the risks. It is also commonsense
-- just because a medical product approved for one use may be found to be safe and
effective for that use, does not necessarily mean that it will be safe and effective for another
use or for another population.
Recognizing that physicians may prescribe treatments off-label in response to individual
patient needs, FDA allows the communication of truthful and non-misleading scientific or
medical information regarding unapproved uses of medical products that may assist
physicians in making treatment decisions. In these instances, FDA has allowed for
manufacturers to respond to requests from physicians about unapproved uses and provide
peer-reviewed journal articles, scientific or medical texts, and clinical practice guidelines.
Following 21st Century Cures, manufacturers are also now able to share health care
economic information with payors to help them better understand the economic benefits of
an approved treatment.These are commonsense approaches that allow doctors to address the individual needs of a
patient, but also ensure that patients are not unnecessarily exposed to unproven or harmful
medical products.
Today, we are here to examine discussion drafts from Representatives Griffith and Guthrie
that would greatly expand the types of scientific information that manufacturers could share
without any FDA oversight. While I understand that medical product manufacturers have
voiced concern about their ability to communicate with doctors about their products, I am
concerned that these drafts would severely undermine the current protections against
marketing unsafe and ineffective medical products. During this hearing, I hope to hear what
materials manufacturers want to share with health care professionals and payors today that
they feel they cannot under current law.
The scientific exchange discussion draft would severely restrict the types of evidence the
FDA has always relied on to determine the intended use of a medical product. It would also
hamstring the agency from holding bad-actors who distribute dangerous drugs or medical
devices accountable.
The preapproval communication discussion draft would blow a hole in the current approval
process by allowing the communication of any scientific evidence or health care economic
information to payors or formularies without any recourse for the FDA to prevent bad actors
from communicating false or misleading information. Allowing manufacturers to
communicate about unapproved products and unapproved uses of their products, reduces
the incentive to go through FDA's approval process. This is grossly irresponsible.
For example, the proposed discussion draft would allow for a manufacturer to publish a
biased scientific study in any medium to constitute "scientific exchange." This could include
simply posting results of a non-peer reviewed study on a company's own website, and there
is no requirement that this information be truthful.
I am concerned these two discussion drafts could expose more patients to medical products
that have never been proven to be safe or effective. One study found that 81 percent of
medications prescribed for off-label purposes had poor or no scientific support, while another
found that patients who received off-label prescriptions were 54 percent more likely to
experience an adverse event as compared to on-label use. These are risks that we simply
cannot ignore.
If there is a need for greater certainty and clarity on the types of communications that
manufacturers are permitted to use under current law, I am willing to have that discussion.
However, broadening communication in the ways proposed under these discussion drafts
would undermine FDA's regulatory review process and the safety and effectiveness approval
standard.
Thank you.

Source