WASHINGTON – Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine.
Scott Gottlieb, the commissioner of the Food and Drug Administration, said recently that drugmakers must “end the shenanigans” that prevent competing products from reaching the market.
Generic drug developers need samples of brand-name drugs to show that a generic copy is equivalent to the original. The maneuvers by brand-name drug firms, Gottlieb said, “frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies.”
The Federal Trade Commission is investigating the practice, which it says can forestall generic competition and “potentially preserve a brand firm’s monopoly indefinitely.”
Legislation to ensure access to drug samples for generic drug manufacturers has broad support in Congress.
Under the bill, a generic drug developer could file a lawsuit, and a federal court could require a brand-name drugmaker to provide samples of its product to a generic company “on commercially reasonable, market-based terms.” The court could also award damages if it found that a drugmaker had refused to sell samples “without a legitimate business justification.”
Brand-name drug companies make several arguments against the legislation. First, they say, it is not needed. The FDA approved 1,027 generic drugs last year, a record number, and nearly 90 percent of prescriptions are filled with generic medicines, suggesting that generic manufacturers have generally been able to obtain the samples they need, the brand-name companies say.
Second, they say, the bill would be a boon to trial lawyers, giving them an incentive to sue brand-name pharmaceutical companies for damages, which could be worth more than sales of the proposed generic drug.
Finally, they say, the legislation could endanger patients because generic drug developers might not follow the strict safety protocols that the government requires for some brand-name drugs.
But the FDA says that “no additional requirements are needed to protect patient safety” in tests to show the equivalence of generic and brand-name drugs. The “testing typically involves a relatively small number of human subjects and a small number of doses and therefore a relatively low level of risk,” the agency said.
The fight over physical samples has huge implications for consumers’ access to affordable medicines.
The FDA says it has received more than 150 inquiries from generic drug companies unable to obtain the samples needed to show that a generic product works the same as a brand-name medicine. Some of the disputes over samples involve drugs that are costly to patients and to the Medicare program and that have experienced sharp price increases in recent years.
“Without generic competition, there is no pressure to drive down the costs of these medications,” the food and drug agency said. Under current law, it said, it cannot compel a brand-name drug manufacturer to sell samples to a generic company.