UPDATED: Bipartisan federal legislation would cut biologics exclusivity to 7 years

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From the get-go, President Obama has pushed for setting the exclusivity of biologic drugs at 7 years instead of 12 in order to get the cost-saving copies to market faster. The idea has never gone anywhere in a stalemated Congress. But in a presidential election year in which Americans’ feelings about drug prices are running high, there is now a bipartisan effort that might have a shot.

Two Democrats--U.S. Rep. Jan Schakowsky and U.S. Sen. Sherrod Brown--have been joined by senior Republican Sen. John McCain in introducing what they are calling the Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act. It would cut the exclusivity period on biologics to the 7 years proposed by Obama back in 2009.

“Far too many Americans are being unfairly burdened by the skyrocketing costs of prescription drugs,” Sen. McCain said. “It’s simply unacceptable that patients have to worry about filling a prescription because they can’t afford to pay for it.”

Rep. Schakowsky pointed out that not only do biologic drugs often carry very high prices when introduced--more than a $100,000 in some cases--drugmakers regularly increase their prices over the dozen years in which competition is prohibited.

Schakowsky used as an example, Novartis' cancer med Gleevec, which he said came to market at a cost of $26,400 in 2001, but today runs $120,000. But as one patent attorney pointed out, Gleevec is not a viable example, because it was not approved under a biologics license. It is a small molecule drug. 

The legislation is already eliciting the expected support and resistance within the industry. Support was expressed by the Generic Pharmaceutical Association (GPhA), many of whose members make or are developing biosimilars.

“As brand and specialty drug costs rise at a concerning rate, the association looks forward to working with Congress and others to ensure timely access to biosimilar medicines,” the association said in a statement. It pointed out that biosimilars have been projected to save the healthcare system anywhere from $44 billion to $250 billion over 10 years.

But the Biotechnology Innovation Organization (BIO), whose membership is made up of many of the companies that have developed biologics, issued a statement saying it “strongly opposes” the proposed exclusivity reduction. “This legislation is a short-sighted attempt to undercut the critical work that innovator companies are doing and would, if enacted, deprive patients of many new treatments and cures in the future.”

The proposed law is being trotted out as the pharmaceutical industry is getting barraged with backlash over what is seen as the exorbitant prices that have been put on many new meds, as well as its practice of routinely ratcheting those up. There are federal investigations and Congressional hearings into drug pricing and state attempts to set limits on drug prices since federal efforts have repeatedly been stymied by a deadlocked Congress.

Reducing the drug costs for consumers is supported by both major party presumptive presidential nominees in different ways. Democratic candidate Hillary Clinton’s plan includes cutting exclusivity on biologics to 7 years, as well as giving Medicare the power to negotiate prices. Republican candidate Donald Trump wants to allow Americans to buy drugs online from countries like Canada and the U.K., where they are cheaper.

- read the Rep. Schakowsky’s announcement 
- here’s the GPhA statement 
- and the BIO statement 

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