Legislation to ensure access to drug samples for generic drug manufacturers has broad support in Congress, from Senator Patrick J. Leahy, Democrat of Vermont, on the left to Senator Mike Lee, Republican of Utah, on the right. A similar bill in the House also has diverse backers, including Representatives Peter Welch, Democrat of Vermont, and Mark Meadows, Republican of North Carolina, who is the chairman of the conservative House Freedom Caucus.
Under the bill, a generic drug developer could file a lawsuit, and a federal court could require a brand-name drug maker 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 drug maker 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 F.D.A. 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 F.D.A. 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.
At a time when researchers are using sophisticated science to develop new treatments and cures, the fight over physical samples — a few thousand pills — sounds mundane. But it has huge implications for consumers’ access to affordable medicines.
The F.D.A. 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.
The Congressional Budget Office estimates that the legislation would save the federal government $3.8 billion over 10 years, mainly because Medicare, Medicaid and other health programs would spend less on prescription drugs. Savings for consumers and private health insurance plans could be much greater.
Lawmakers of both parties pushed for the legislation to be included in a far-reaching budget bill signed by Mr. Trump in February, but it was dropped at the last minute.
Even without action by Congress, generic drug companies say the denial of drug samples needed for testing may violate federal antitrust law because it tends to perpetuate a monopoly for the makers of some brand-name medications. But it typically takes years for courts to resolve such claims.
Mylan, a generic drug company, wants to obtain samples to develop a generic version of Revlimid, a brand-name cancer medicine sold by Celgene. At a court hearing in Newark in December, Jonathan M. Jacobson, a lawyer for Mylan, told a federal district judge that “Revlimid costs patients who are dying $20,000 a month.”
“These are some of the most ill patients in the world,” he said, and “if there were generics on the market, the price would be much lower, and people would live longer.”
Celgene said in court papers that it had no obligation to help a potential competitor and that it had “valid business justifications for declining to sell samples on the terms demanded by Mylan.” Moreover, Celgene said its overriding concern was for the safety of patients.
But Mylan, the generic drug company, said this was no excuse because it had devised safety protocols similar to those followed by Celgene.
The secretary of health and human services, Alex M. Azar II, has repeatedly said that drug prices are too high. The administration, he said, will soon roll out “a whole slate” of proposals to reduce those prices.
Mr. Azar has suggested that private companies — pharmacy benefit managers — should have a role in negotiating prices for drugs under Part B of Medicare. Those drugs are typically administered by infusion or injection in doctor’s offices and hospital outpatient departments.
News credit : Nytimes