It’s no secret that generic drugs cost less than their name-brand equivalents, for example, using other ibuprofen products besides Advil or other acetaminophen products besides Tylenol, but just how much less they cost may surprise you. According to the Food and Drug Administration (FDA), the average generic costs only 15 to 20 percent as much as its branded counterpart. And according to the FDA, they’re no less effective either. As a result, generics have grown from 18 percent of the market three decades ago to 80 percent today, saving consumers $1.2 trillion in the past decade.

Congressional bill H.R. 2841, the Fair Access for Safe and Timely Generics Act (also known as the FAST Generics Act), was introduced by Rep. Steve Stivers (R-OH15) and would extend those benefits even further by increasing consumer access to generics.

What it does

First things first — why do generics cost so much less? The main reason is because a 1984 bill removed most of the requirements for research, development, and regulatory approval for generic drugs. Previously, generics had to jump through all the same hurdles and invest the same billions as branded drugs did. (The 1984 bill, popularly known as the Hatch-Waxman Act, was partially named for Sen. Orrin Hatch [R-UT], who is still a sitting senator today.)

Yet some experts believe generics could actually come down even further in price than they already have, without diluting their quality. According to a press release announcing the current bill, some companies use a loophole in FDA drug safety programs and withhold access to drug samples for generic manufacturers. Thus, not only are some generics constrained in terms of their market reach, but when/if they do reach consumers the price increases.

The bill closes these loopholes, especially in a program enacted in 2007 called Risk Evaluation and Mitigation Strategies (REMS). Under this change, generics would be able to go to court and seek damages if unfairly denied access to product samples.

What supporters say

The bill has nine co-sponsors, a bipartisan mix of five Democrats and four Republicans. Supporters say the bill will save money and expand consumer choice. “Our legislation will save consumers billions of dollars by ensuring timely competition in the market and preventing unfair delays for patients seeking more affordable options for their medications,” said co-sponsor Rep. Peter Welch (D-VT0).

President and CEO of the Generic Pharmaceutical Association Ralph Neas called the bill an improvement in speed and consumer options. He noted, “The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually… The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers, at the same time putting safeguards in place to protect public health.”

What opponents say

Stacey Worthy and Stephanie Curtis warn in Health Affairs that “While requiring that REMS drugs go to generic marketers for bioequivalence testing, the ACT does not contain sufficient safeguards to prevent harmful exposure to these medicines.” They outlined a hypothetical example in which “If bad actors took advantage the FAST Act’s vague definitions to acquire the drug under false pretenses, the medication could end up in the hands of a physician without training who might unwittingly administer it to a woman who is pregnant.”

The Pharmaceutical Research and Manufacturers of America (PhRMA), the main organization for most branded medicines, said “We are concerned [the bill] could undermine these FDA-approved programs intended to address very serious risks to patients.” In the last 17 years the pharmaceutical industry has spent more money on lobbying that any other industry, with the aforementioned organization PhRMA leading the way with $16.6 million.

Odds of passage

Money talks, which was a contributing factor in a previous version of the bill expiring without a vote in 2014. But with more bipartisan cosponsors this time and with healthcare costs rising — even if they are growing at the slowest rate since 1960 — this bill could stand a chance. It has been referred to the House Energy and Commerce Committee.