Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) introduced the FAST bill on September 18, which would amend the FD&C Act (Federal Food, Drug, and Cosmetic Act) to “clos[e] federal loopholes to ensure consumers have increased access to less costly generic drugs by increasing market competition and eliminating bureaucratic red tape.”
Stivers said in a statement some drug companies “abuse Food and Drug Administration (FDA) drug safety programs” to prevent generics manufacturers accessing their samples for bioequivalence testing and developing competitor medicines.
The bill singles out Risk Evaluation and Mitigation Strategies (REMS) – plans the FDA can impose on drugmakers beyond the standard safety labelling. REMS can require distributors to follow specific procedures before shipping or dispensing drugs, such as extra patient education or requiring users to take a pregnancy test or undergo liver function monitoring. These obstacles can delay or prevent supply of medicines to rival companies.
The Congressman said companies use FDA safety programmes as a “smokescreen” for delaying generic market entry and preserving high drug prices, pointing to a study by Matrix Global Advisors which claims the practice costs US patients and government a combined cost of $7.2bn (€5.7bn) annually.
‘Change patent law’
But the CEO of pharmacy pricing software firm Truveris told in-Pharmatechnologist.com that marketing clashes are a “deeper-rooted issue than just this bill.”
Because of the way patents are issued in the US, in practice drugs do not receive a full 15 years of marketing exclusivity, sometimes having only three to seven years to recoup costs, Bryan Birch told us.
“Patents are issued when the drug could still be in trials, rather than in use. It’s often way before they’re ready to be sold on the market.”
The ramifications, he said, go beyond manufacturers’ determination to prevent rivals getting their hands on drug samples for generics research.
“The branded manufacturer needs to recoup their investment over a shorter period of time, so they raise the price of their branded product during the time they have patent protection.”
Increasing the amount of time before a product goes off-patent in the US would go a long way toward lowering disproportionately high drug prices within the country, said Birch.
Birch called for “a harder look at the patent laws” to help resolve these problems. “If the US government changed the patent life cycle they could monitor more closely the wholesale acquisition cost of the drug, in an effort to make sure they [drug companies] are not recouping too much.”
Some services companies act as middle men for generics companies and help source medicines “below the radar” for bioequivalence testing. Innovator companies will cut off supply to wholesalers if they suspect a medicine is being used in comparator tests, Biotec Services International told in-Pharmatechnologist.