Tackling critical drug shortages will be a top bipartisan priority for the House in the coming legislative session.
House Committee on Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) announced that her committee will be holding hearings next week on shortages of pharmaceutical supplies in advance of reviewing five pieces of legislation to address the crisis looming over the healthcare sector.
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"Cancer patients in need of lifesaving treatments have been rocked by shortages in generic medicines driven, in large part, by economic issues and government policies. Addressing the root causes of these shortages will require a multifaceted approach," Rodgers and Subcommittee on Health Chairman Brett Guthrie (R-KY) said.
The Food and Drug Administration regularly updates its drug shortage list, which now lists 136 medications or medical supplies in short supply. This includes various cancer drugs, such as methotrexate; antibiotics, such as penicillin and clindamycin; pain medications, such as morphine and lidocaine; and cardiac medication, such as atropine and digoxin.
Sterile water for wound irrigation, sodium chloride for IV fluids, and dextrose for blood sugar stabilization are also facing supply shortages.
In May, the FDA responded to an inquiry letter from the committee, saying that one of its primary problems in monitoring the supply chain of pharmaceuticals is the lack of available data, with only 44% of registered establishments that are supposed to report to the agency doing so consistently.
"FDA cannot, nor should it be in FDA's remit to, require a pharmaceutical company to make a drug or make more of a drug," Kimberlee Trzeciak, the FDA's associate commissioner for legislative affairs, wrote. "The Agency's core efforts on drug shortages revolves around working with drug manufacturers when we know there is a drug shortage or potential [for one] to identify the cause and extent of the shortage [and find a solution.]"
In late August, 11 Republican governors sent a letter to bipartisan leadership in the House and Senate demanding that Congress take action at the federal level, particularly with respect to transparency from the FDA.
"States are taking what limited action we can to combat prescription drug shortages [but] to create real change, the states need Washington to take action," Gov. Kristi Noem (R-SD) wrote.
Here are details on the piece of legislation under consideration by the committee this term to address those concerns.
The Stop Drug Shortages Act: Sponsored by Rodgers, the Stop Drug Shortages Act would supply a variety of possible avenues for reform from a supply-side market perspective. The bill is meant to reform several provision of Medicare and Medicaid pricing for pharmaceutical products, exempting generic injectables from federal subsidy programs. Rodgers's bill would also provide an enforcement mechanism for the secretary of the Department of Health and Human Services to enforce existing regulations requiring manufacturers to report supply chain disruptions. Additionally, the bill aims to incentivize greater domestic pharmaceutical manufacturing.
Drug Shortage Prevention Act (HR 3008): Sponsored by Rep. Sara Jacobs (D-CA), HR 3008 would require manufacturers to report interruptions in production anticipated changes in demand for lifesaving pharmaceutical products, which are defined as those "intended for use in the prevention or treatment of a debilitating disease or condition in humans or animals, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency." Manufacturers would need to report to the FDA within six months of experiencing a disruption.
Drug Origin Transparency Act (HR 3810): Sponsored by Rep. Anna Eshoo (D-CA), HR 3810 seeks to identify clearly on labeling the suppliers of pharmaceutical ingredients and better identify processes of the manufacturing supply chain for medications.
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Ensuring Access to Lifesaving Drugs Act (HR 3793): Sponsored by Rep. Elissa Slotkin (D-MI), HR 3793 would enable better data collection on pharmaceutical production from the HHS secretary and would extend expiration dates for lifesaving medications and products. Products that would fall under this category include those that are defined as life-saving in HR 3008.
Patient Access to Urgent-Use Pharmacy Compounding Act (HR 167): Sponsored by Rep. Morgan Griffith (R-VA), HR 167 relaxes requirements for compounding drugs — or the process by which a pharmacist or physician can combined pharmaceutical ingredients to make medication. Although the practice is strictly regulated by the FDA, this bill would allow for pharmacists and physicians without specific FDA clearance to engage in compounding if they have made reasonable attempts to fill prescriptions. The act would also require that physicians or pharmacists keep and report accurate records of compounded drugs as well as stipulate on prescription labeling that the medication is not made by the manufacturer.