Schakowsky Opening Remarks at Hearing on Pharmaceutical Product Hopping
Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) delivered the following opening remarks today at a Consumer Protection and Commerce Subcommittee hearing entitled “Protecting Consumers from Pharmaceutical Market Gaming Tactics:”
Throughout today’s hearing, you will hear many different terms used to describe the problem we are trying to address: “product hopping,” “hard switches,” “soft switches,” and “evergreening.” But whatever the word or phrase, the bottom line is: drug manufacturers are gaming the system to make more money at consumers’ expense. And that has to stop.
Big Pharma says that high prices and exclusivity are essential to innovation. But competition is actually most central to innovation—and the opposite of what Big Pharma wants. Experts suggest that about 78% of the drugs that get new patents are NOT new drugs. They are new patents for existing drugs.
Instead of truly innovating, drug manufacturers are taking advantage of the anticompetitive environment we have created by recycling old medicines into new forms. The problem goes beyond several bad actors you will hear about over and over again today—Humira, Revlimid, Suboxone, Namenda, Prilosec.
Of the 100 best-selling drugs on our market, about 70% had their protection extended at least once, and 50% have had their protections extended more than once. Many companies are actually withholding new and beneficial discoveries about their drugs from consumers until they can use the innovation to block competition.
Mr. Carrier’s testimony provided a series of alarming examples:
One manufacturer’s main reason for not seeking FDA approval for off-label uses of their drug was that it “wanted to reserve them for a…promotional campaign for its reformulated product.”
Another manufacturer obtained FDA approval for a once-daily version of their Alzheimer’s treatment, but waited three years, until generic competition for their twice-daily drug was imminent, before they released it.
Big Pharma actually blocked the innovation they claim to treasure—innovation that could have helped patients—until the timing was most profitable.
I am proud to preside over this hearing in the Consumer Protection Subcommittee because Congress must take direct action to protect American consumers from the deceptive actions that drug manufactures take to gouge consumers.
FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs. FDA does not adjudicate patent claims, and I agree with the agency’s conclusion that they should not be tasked with doing so.
And though the FTC has brought some cases for anticompetitive practices in the prescription drug market, it does not have explicit authority to challenge anticompetitive hard and soft switches. Americans should not have to hope the FTC can stop Pharma’s gaming of the prescription drug market—they should be able to count on it.
And Americans should not have to wait years for costly lawsuits to play out—or find that the generic has decided to settle with the brand company for a hefty sum to keep their drugs off the market, also known as Pay-For-Delay.
I look forward to learning from our witnesses today as I craft a bill to protect consumers from Big Pharma’s gaming tactics. This legislation will encourage the courts to view these gaming practices as anticompetitive and discourage manufacturers from engaging in these practices to begin with.
We owe it to the American people to stop Big Pharma’s patent games, and I will do everything in my power to do so.