The Claim: “Congresswoman Abby Finkenauer voted for the CREATES Act, allowing us quicker access to generic prescription drugs. Generic prescription drugs offer the same benefits as name brand drugs but at a much lower price. This leads to our everyday medications being up to 85 percent less expensive.”
Source of claim
This statement about the Democratic freshman U.S. representative from Eastern Iowa’s 1st Congressional District appears in a mailer sent to constituents by political action committee Center Forward, which identifies itself as a centrist organization. It also has roots in the Blue Dog Coalition, a caucus of U.S. Democratic members of Congress who hold centrist views. The premise of the mailer was to praise Finkenauer for “working to lower the cost of prescription drugs.”
To check this claim, we first will look at the Creating and Restoring Equal Access To Equivalent Samples Act, or the CREATES Act.
To create biosimilar or generic drugs, manufacturers need samples of products from name brand companies for testing the product before they can obtain approval from the U.S. Food and Drug Administration.
According to the legislation’s description, the CREATES Act would block certain tactics used by name-brand drug manufacturers to delay releasing samples of their products to generic producers. Manufacturers can refuse to sell the quantity needed for the development process or employ special safety protocols as a way to keep generic producers from obtaining their products, keeping competition off the market.
Among its policies, CREATES would allow generic drug manufacturers to sue other producers in federal court to obtain these samples and would give the FDA more discretion in approving alternative safety protocols.
The Campaign for Sustainable Rx Pricing, which is part of the National Coalition on Health Care, stated this market-based approach would bring generic products to the market more quickly as it closes the loophole pharmaceutical companies use to offset competition.
The CREATES Act, first presented to Congress in 2016, was recently reintroduced to a vote as a part of an omnibus bill, H.R. 987, that passed the Democratic-controlled House on May 16. According to a roll-call vote, Finkenauer did vote for H.R. 987.
The bill has not been brought before the Republican-controlled Senate for a vote.
The Congressional Research Service stated in a 2019 report there’s little legal recourse for generic drug manufacturers that have been denied access to brand-name samples.
ARTICLE CONTINUES BELOW ADVERTISEMENT
However, it’s also unclear how many generic product developers would face this hurdle, as the report also states that only “some brand products” are subject to restricted distribution limits. For medications subject to normal distribution channels, obtaining samples “generally does not present a significant hurdle,” the Congressional Research Service report stated.
Center Forward, the political action committee behind the mailer, provided a sheet from the Center for Drug Evaluation and Research, a branch of the FDA, for sourcing on its statements about drug costs.
The FDA requires a generic drug to be bioequivalent as its name-brand counterpart, and must have the same “active ingredient, strength, dosage form and route of administration,” the sheet stated. In addition, manufacturing, testing and packaging must pass the same standards held to name brand drugs.
Research published in March 2019 in the medical journal PLOS Medicine confirmed through a data analysis of more than 3.5 million patients that the use of generic prescriptions “provided comparable clinical outcomes” to the use of name brand medications for chronic conditions that included diabetes, depression and anxiety.
The FDA stated generic manufacturers sell their products for lower prices because they are not required to repeat costly clinical trials name-brand producers undertake to create new medications.
As a result, generic drug prescriptions cost an average 80 to 85 percent less than their name- brand counterparts, the FDA stated.
“In 2010 alone, the use of FDA-approved generics saved $158 billion,” according to the sheet.
In addition, multiple generic companies often are approved to market a single product. Competition in the marketplace “often results in lower prices,” the FDA fact sheet stated.
ARTICLE CONTINUES BELOW ADVERTISEMENT
A 2019 report from the AARP Public Policy Institute studied retail prices of prescription drugs for older adults and found that name-brand drugs cost 18 times more than their generic counterpart in 2017. By comparison, the average cost of a generic prescription for older adults was $365 a year while name-brand medication cost $6,798.
For the most part, the claims made by Center Forward are sound.
Finkenauer did vote in favor of the CREATES Act, which is aimed at creating quicker access to prescription drugs by offering generic manufacturers an avenue to obtain brand-name samples. By increasing access to these samples, the legislation would create more competition in the market.
This mailer also is accurate in its claims on generic medications. Research has shown prescriptions made by generic manufacturers do offer the same benefits as name brand drugs, as both producers must meet the same federal requirements.
Federal officials have also stated generic medications are up to 80 percent to 85 percent less expensive on average than their name brand counterparts, thus supporting the mailer’s final claim.
What this mailer leaves out is the impact this legislation would have — if were to actually become law. It’s unclear whether this would have a major effect on the market, or would be just a drop in the bucket compared with other factors influencing prescription drug costs in the United States.
Nonetheless, the statement is accurate so we will give it an A.
The Fact Checker team checks statements made by an Iowa political candidate/officeholder or a national candidate/officeholder about Iowa, or in ads that appear in our market.
Claims must be independently verifiable.
We give statements grades from A to F based on accuracy and context.
If you spot a claim you think needs checking, email us at email@example.com.
This Fact Checker was researched and written by Michaela Ramm of The Gazette.