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S. 2740 (116th): Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

Many hands make light work. At 335 pages, March’s $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act only came together so quickly by incorporating provisions of 29 other bills pending before Congress. So what were some of these other bills?

Rapid Coverage for Coronavirus Vaccines Act

This requires private health insurance plans to cover any covid-19 treatments or vaccines.

It was previously introduced in the Senate on March 17 as bill number S. 3505, by Sen. Doug Jones (D-AL).

“We have to do everything we can to mitigate the spread of covid-19. This bill will allow Americans to rapidly access vaccines for this novel coronavirus as soon as they are available,” Sen. Jones said in a press release upon introduction. “Congress should immediately pass [it] as part of a robust response to this virus.”

Commission on America’s Medical Security Act

This forms a commission to study and make recommendations regarding America’s reliance on foreign drugs, medicines, and medical equipment such as ventilators. Their recommendations are to include best options to increase domestic medicine and medical equipment manufacturing.

The Senate version has been introduced on March 12 as bill number S. 3478, by Sen. Richard Durbin (D-IL). The House version was introduced the next day on March 13 as bill number H.R. 6282, by Rep. Raul Ruiz (D-CA36).

“We have a real dependence when it comes to developing medicines and drugs on these two countries [China and India] and many others… and it raised a question in my mind as to whether we should do something thoughtful and prospective in terms of dealing with global dependence on medicine, medical devices, and medical supplies,” Sen. Durbin said on the Senate floor upon introduction. “So I’m introducing legislation this week calling for the creation of a commission to look at this dependence, to measure it today.”

COVID-19 Funding Accountability Act

This establishes a committee to oversee the roughly $2 trillion in spending from the CARES Act, the most expensive single spending bill in American history.

It was previously introduced in the Senate on March 24 as bill number S. 3578, by Sen. Chuck Grassley (R-IA).

“My proposal would impose strict congressional oversight over the Treasury Department fund that is tasked with extending lending and other assistance to air carriers and American companies that have been hard hit by the coronavirus pandemic,” Sen. Grassley said on the Senate floor upon introduction. “It mirrors closely the language that this chamber adopted in 2008, during consideration of the Troubled Asset Relief Program [commonly referred to as the bailouts].”

GovTrack Insider recently covered a bill that would allow for the reinstatement of Glenn Fine as the committee’s chair, after President Trump demoted him shortly following his appointment.

Improving Care in Rural America Reauthorization Act

This increases the annual funding for certain rural health programs by more than +75%, from $45 million a year to $79.5 million a year.

It was previously introduced in the Senate on March 11 as bill number S. 3437, by Sen. Kelly Loeffler (R-GA).

“We must ensure Americans have access to quality health care services regardless of their background or zip code,” Sen. Loeffler said in a press release upon introduction. “For a state like Georgia, where 120 of 159 counties are considered rural by the Georgia Department of Community Health, these programs are critically important.”

“Through these grant programs, we’re working to close the health care services gap by connecting medical professionals with rural patients, streamlining innovation, removing barriers to competition and increasing access to services and technology.

United States Public Health Service Modernization Act

This establishes a “Ready Reserve Corps” within the existing 6,000+ member U.S. Public Health Service (USPHS) Commissioned Corps. Though relatively little-known, the group is one of America’s eight uniformed services along with the Army, Navy, Air Force, Coast Guard, Marines, and Space Force.

The officers work full-time for other federal agencies and departments, but could be deployed (like soldiers) during national emergencies. However, when that occurred, that left the existing full-time positions temporarily vacant. This new law ends that problem by creating a reserve system such as the Army has.

It was previously introduced in the Senate on October 17 as bill number S. 2629, by Sen. Mike Rounds (R-SD). It had passed the Senate on January 9 by voice vote, a procedure for relatively noncontroversial bills in which no record of individual votes is cast.

“We must make certain vital healthcare services remain available to our citizens when Commissioned Corps Officers are called away from their duty stations,” Sen. Rounds said in a press release upon introduction. “By creating a Ready Reserve Corps within USPHS, we’ll be better equipped to fill these vital positions, such as doctors and nurses at IHS facilities, when the Regular Corps Officers need to respond to a national emergency.”

Protecting Jessica Grubb’s Legacy Act

This changes confidentiality rules for substance abuse disorder patients’ medical records. The records can now be shared with the prior written consent of the patient, a change intended to prevent physicians from accidentally prescribing opioids to patients who are in recovery from opioid addiction.

It had previously been introduced in the Senate on March 3 as bill number S. 3374, by Sen. Joe Manchin (D-WV).

“By making changes to the existing regulations regarding the medical records of patients with substance use disorder, we can save thousands of lives,” Sen. Manchin said in a press release upon introduction. “No one should go to the doctor expecting to receive help and instead be thrown back into the nightmare of addiction. We must do more to combat this crisis as a country. The [bill] will help make sure we are combatting this epidemic, not contributing to it.”

Over-the-Counter Monograph Safety, Innovation, and Reform Act

This reformats the Food and Drug Administration (FDA) regulatory process for approving new over-the-counter drugs and medicines, a process which previously often took years.

It was previously introduced on October 30 by former Sen. Johnny Iskason (R-GA), who retired in December for health reasons. It then passed the Senate by 91–2 in December, with only Sens. Richard Burr (R-NC) and Rick Scott (R-FL) opposing.

“It is past time to modernize and overhaul our woefully outdated over-the-counter drug approval process,” former Sen. Isakson said in a press release upon introduction. “I’m reintroducing the [bill] to help ensure that the health products in Americans’ medicine cabinets and on supermarket shelves are effective and accessible for patients, that innovations can be made well into the future, and that we promote competition to bring down costs for consumers.”

Which types of bills were incorporated into the CARES Act?

Some other quick stats about the 29 bills incorporated into the CARES Act:

  • Party of sponsor: 21 (72%) had a Democrat as lead sponsor, versus eight (28%) with a Republican as lead sponsor.
  • Partisanship of cosponsors: by GovTrack’s count, 20 (69%) had largely bipartisan cosponsorship, four (14%) had entirely or almost-entirely Democratic cosponsorship, two (7%) had entirely or almost-entirely Republican cosponsorship, and three (10%) had no cosponsors at all.
  • Dates introduced: 16 (55%) were introduced on March 11 or later, approximately the time that most quarantine orders were put into effect.
  • Status before the CARES Act: 22 (76%) had not yet received a committee vote, four (14%) had passed a congressional committee, and three (10%) had passed either the House or Senate.
Last updated May 28, 2020. View all GovTrack summaries.

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Sep 13, 2021.

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.