IN THE SENATE OF THE UNITED STATES
December 19, 2019
Mr. Braun introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs, and for other purposes.
This Act may be cited as the
Conditional Approval Act.
Conditional approval of new human drugs
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end of the following:
Conditional and time limited approval pathway for new drugs
The Secretary shall, at the request of the sponsor of a new drug, grant provisional and time-limited approval of such drug under this section, if the Secretary determines that—
it is likely that the sponsor will be able to provide comprehensive clinical data after such drug is conditionally approved;
such drug is intended for the treatment, prevention, or medical diagnosis of a seriously debilitating disease, a life-threatening disease, or a chronic condition;
the expected benefits of the drug outweigh the potential risks to patients, taking into account the fact that additional data are still required to assess the drug and the severity of the underlying disease or condition the drug is intended to treat;
there are no existing meaningful treatments for the disease or condition that the drug is intended to treat;
confirmatory clinical trials are difficult or costly to conduct; and
such drug is intended to treat a disease or condition for which no more than 2 meaningful treatments currently exist.
Not later than 180 days after the date on which the Secretary receives a request for conditional approval under subsection (a) with respect to a new drug, the Secretary shall require the sponsor of such drug to—
complete in a timely manner clinical investigations to provide full demonstration of safety and effectiveness as described in section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, as applicable;
conduct clinical trials other than confirmatory trials, to demonstrate a certain degree of safety and efficacy of the drug; and
demonstrate that necessary post-market surveillance and risk-management tools are in place with respect to the drug.
Period of conditional approval
The period of conditional approval for a drug under this subsection is effective for 1 year, and is renewable by the Secretary for up to 4 additional 1-year terms. A conditional approval shall be in effect for not more than 5 years from the date on which conditional approval is first granted.
If any conditionally drug approved under this section is not brought to market within 3 years of the conditional approval, any conditional approval granted under this section with respect to such drug shall be deemed invalid.
As a condition on receipt of conditional approval under this section, the Secretary shall require the sponsor of the drug to agree to the following:
Complete in a timely manner such clinical investigations to provide a full demonstration of effectiveness as the Secretary determines to be necessary for approval of the drug under section 505 of this Act or section 351 of the Public Health Service Act, as applicable.
Submit to the Secretary an annual report on the progress of the sponsor in conducting the clinical investigations required under this section.
Ensure that all labeling and promotional materials for the drug bear the statement
conditionally approved by the FDA pending a full demonstration of effectiveness under applicable ___ (specifying the application number assigned by the Secretary in place of the blank).
Applying for full approval
The sponsor of a drug granted conditional approval pursuant to this subsection may, at any point, submit an application for full approval as described under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, as applicable.
Utilization of real world evidence to support full approval
The Secretary shall allow the use of real world evidence, as defined in section 505F(b), and collected by the sponsor of a drug during the duration of conditional approval granted approval to this subsection, to supplement an application for full approval, in addition to other post-approval studies.
Limitation on liability
With respect to any claim under State law alleging that a drug sold or otherwise made available pursuant to a grant of conditional approval under this subsection is unsafe or ineffective, no liability in a cause of action shall lie against a sponsor or manufacturer, unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intention tort under any applicable State law.
Rule of construction
Except as set forth in subparagraph (A), nothing in this subsection shall be construed to modify or otherwise affect the right of any person to bring private action under any Federal or State product liability, tort, consumer protection, or warranty law.
In this section:
Seriously debilitating disease
The term severely debilitating disease means a disease or condition that causes major irreversible morbidity.
The term life-threatening disease means—
a disease or condition where the likelihood of death is high unless the course of the disease is interrupted; or
a disease or condition with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
The term chronic condition means a disease or condition that—
usually lasts for 3 months or longer; and
requires ongoing medical attention; or
limits activities of daily living.
Regulations and guidance
Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations and guidance for carrying out section 524B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
Section 505(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)) is amended by inserting
, or there is in effect a conditional approval under section 524B with respect to such drug before the period.