Office of Drug Manufacturing
The bill would amend Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) by adding a new §310C, Manufacturing Of Drugs. Subsection (a) would establish the Office of Drug manufacturing in the Department of Health and Human Services. The purpose ODM would be to:
To increase competition, lower prices, and address shortages in the market for prescription drugs, including insulin, asthma and chronic obstructive pulmonary disease (COPD) inhalers, naloxone, epinephrine auto-injectors, and antibiotics,
To reduce the cost of prescription drugs to Federal and State health programs, taxpayers, and consumers, and
To increase patient access to affordable drugs and associated devices.
The Office would:
Prepare and submit applications for approval to the FDA, or enter into contracts for such submission, for the manufacture of applicable drugs,
Acquire rights to manufacture applicable drugs as authorized under this section,
Manufacture, or enter into contracts with entities, with preference for nonprofit entities and public partners, to manufacture, applicable drugs as authorized under this section,
Determine a fair price for each applicable drug,
Sell manufactured applicable drugs at a fair price, and
Manufacture, or enter into contracts with entities, with preference for nonprofit entities and public partners, to manufacture active pharmaceutical ingredients for use by the Office or for sale to other entities.
ODM would be expected to sell the drugs or active pharmaceutical ingredients manufactured by, or for, the Office and use the funds from those sales to finance the activities of the Office.
Moving Forward
Schakowsky is a member of the House Energy and Commerce Committee to which this bill was assigned for consideration. This means that there could be sufficient influence to see this bill considered in Committee. Unfortunately for Schakowsky and her ten Democratic cosponsors, there would be unanimous opposition to the bill from the Committee’s Republicans. This bill will not be going anywhere in this session of Congress.
Commentary
When this bill was introduced, I noted that:
“I will be watching this bill for language and definitions that would include chemical manufacturing safety and security issues within the scope of responsibility of the proposed Office. I really do not expect to see either.”
I was right, this bill has nothing to do with chemical safety or security. In fact, having a government agency as the manufacturer of record would likely negate the coverage of many OSHA and EPA regulations as they do not apply to government agencies for the most part.
While Republicans will have a kneejerk reaction to this ‘socialist medical manufacturing’ proposal, something has to be done about bringing down the cost critical medications. Medicinal manufacturers have to recover their costs of development and that is certainly contributing to the costs. Unfortunately, this bill would probably have little effect on reducing or eliminating those costs as the developers would recoup those costs when they sold the government the rights to the manufacture the medications.
I think that the crafters of this bill made a serious political mistake when they included language that implied that the ODM would own the means of production (i.e.: “manufacture [emphasis added], or enter into contracts with entities” to manufacture. That idea would never fly with any Republican congresscritter, or even with many moderate Democrats. Paying manufacturers to make specific drugs for use by government agencies sounds a lot less ‘socialist’ and may have at least been considered for discussion.
In any case, this bill is not going anywhere, and it is really outside of the scope of things that I intend to cover here, so this will be my last word on the legislation.