It’s been nearly 30 years since Congress kick-started the generic drug industry by passing the Hatch-Waxman Act, the 1984 law that made it easier for pharmaceutical companies to sell copycat pills as long as they could prove the drugs were identical to the brand-name versions. Today, the Food and Drug Administration and nearly every other major health authority agree that generic drugs are safe and effective. Indeed, 84 percent of all prescriptions in the United States were dispensed as generics last year, and in many states pharmacists are required to dispense the generic version of a drug unless a doctor specifies otherwise.
The reason, from a public health perspective, is clear: Many generic drugs cost pennies per pill, yet pack the same punch as brand-name medicines.
So why can’t they get more respect?
Television writers aren’t the only ones who suspect that generic drugs are somehow subpar. In 2007, researchers at Brigham and Women’s Hospital in Boston surveyed more than 1,000 patients about their views on generic drugs. Participants agreed overwhelmingly that generics were “a better value” than branded drugs, and fewer than 10 percent believed that generic drugs caused more side effects. More than half expressed the opinion that Americans should be taking more of them. But when it came to the patients themselves, only about 38 percent said they preferred generics over brand-name drugs.
“It’s some bizarre thing that’s in the deepest part of their psyche,” said Dr. William Shrank, the study’s lead author. “They have all the pieces of information to make the right decision, but there’s something that’s holding them back.”
Some studies have found that lower-income patients — those who could benefit the most from generics — are among the groups that are most skeptical. In 2011, for example, researchers at the University of Alabama, Birmingham, noticed that participants in a community outreach program in rural Alabama, most of whom were poor and African-American, were using brand-name medications even though cheaper generics were available. Because of the higher cost, some weren’t refilling their prescriptions when they ran out.
Intrigued, the researchers set out to discover why. In an article published in 2012 in the journal Preventing Chronic Disease, patients gave some reasons that seemed straightforward: brand-name drugs were perceived as being of higher quality, or of causing fewer side effects.
But other explanations were more complex. Some of the patients said they felt forced to “settle” for lesser drugs because they were poor and black.
“I think that the doctors and manufacturers use us as guinea pigs to see which ones we will buy the most,” one woman told the researchers. Another said, “We settle for that because we’re trying to do the best we can with the fixed income we have.”
Other studies have shown that people with higher education and income levels are more likely to view generics positively — those groups may see choosing generics as a smart financial choice, said Dr. Keri Sewell, the Alabama study’s lead author. Her research showed that “increasing the acceptance of generic medications is more complicated than just educating people about their equal efficacy,” she said. “There was a lot of mistrust of doctors and insurance companies, and also people feeling like they were at the mercy of the medical system.”
Skepticism about generic drugs is not limited to the poor and disadvantaged, however. One recent study found that almost 50 percent of doctors held negative views of the quality of generic medications, and more than a quarter said they would rather not use generics for either themselves or their families.
Part of the problem, some suspect, is the name itself: “generic” conjures up the budget aisle at the local supermarket. And while everyone knows about Pfizer, and many have seen the television commercials for Lipitor, its best-selling cholesterol pill, the name of Lipitor’s generic equivalent, atorvastatin, doesn’t exactly roll off the tongue.
The trouble is, generic Lipitor isn’t the same as generic Kleenex. Under the law, generic drugs must contain the same active ingredient and the same dosage, and must work the same way in the body as the brand-name equivalent. “When you see generics in other places, there are meaningful differences,” said Dr. Shrank. “But when it comes to drugs, it’s a highly regulated business — there’s really no difference.”
Generic drug makers haven’t been doing themselves any favors recently. The shutdowns of several plants that make generic injectable drugs have led to a nationwide shortage of critical medicines. Some of the factories halted or slowed production after F.D.A. inspectors made toe-curling discoveries like finding spiders in supposedly sterile vials of medicine, or a barrel of urine in a storage area.
Last fall, the F.D.A. took the unusual step of declaring that one dose of a generic form of Wellbutrin, an antidepressant, was not the therapeutic equivalent of the brand-name pill. The acknowledgment followed years of consumer complaints that generic versions of Wellbutrin weren’t working properly.
And earlier this year, the generic drug maker Ranbaxy agreed to pay $500 million to settle federal charges that it sold subpar drugs and made false statements to the F.D.A. about its manufacturing practices in India, where it is based. The settlement was the largest in United States history involving a generic manufacturer and drug safety.
SOME have said that the rapid expansion of the generic drug industry over the past decade — and the influx of drugs from overseas companies in countries like India — has compromised quality. A law passed last year imposes new fees on generic-drug companies that are supposed to help the F.D.A. step up its inspections of overseas manufacturing sites, but the agency has acknowledged that foreign factories receive less scrutiny than plants in the United States.
Over the past decade, health insurers, large employers and major health care providers have led the switch to generic drugs because they cost so much less — often about 80 percent less than the brand-name drug. Patients in most private health plans must use generic drugs or pay higher co-payments, and drug-benefit managers have perfected the art of converting patients from a brand to a generic as soon as a drug loses its patent protection.
Those efforts have paid off: spending on drugs actually decreased by 1 percent in 2012, the first decline since the research firm IMS Health first began tracking such numbers in 1957. Researchers there attributed much of the decline to increased use of generic drugs and the recent loss of patent protection of blockbusters like Lipitor. Experts caution that this golden era won’t last forever — many of the newer, more complex drugs coming on the market will be more difficult to copy cheaply, and fewer big drugs are set to lose their patent protection in the coming years.
Still, the savings are significant: the generic industry’s trade group calculated that generic drugs saved $1 trillion over the past decade, including almost $193 billion in 2011 alone.
What does this mean for consumers? Despite lingering mistrust, the debate over generic drugs has largely ended — we’re all inmates in that fictional women’s prison. And most experts would agree there’s probably nothing wrong with that.
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