The next big question for health products is: Which ones are the best?
The new U.S. Food and Drug Administration (FDA) rule is expected to be announced on Thursday, the final day of the agency’s public comment period.
The FDA’s announcement of its guidelines is expected at a meeting of the National Association of State Boards of Pharmacy, the industry’s main trade group.
The American Chemistry Council, a trade group representing pharmaceutical companies, says the agency is trying to create a standard that is not based on price.
But the group says the guidelines are likely to make some drugs more expensive than they were before.
“The agency is moving away from the current policy of limiting prices to the benefit of consumers and physicians, and is instead focusing on ensuring that the benefits of a product are shared equally with the consumer,” said Gary Shapiro, the group’s executive vice president for health policy.
A typical example is the FDA’s use of price caps to regulate the price of a drug used to treat hypertension and diabetes, or to control the price on a heart medication used to manage heart disease.
The rule, which has yet to be formally released, is designed to help ensure that drug companies do not gouge patients by raising prices that can make a drug more expensive or less effective, said Michael Balsamo, an FDA spokesman.
The agency wants to ensure that any drugs that might be priced too high are less effective than they otherwise would be, he said.FDA guidelines are a “federal mandate” that has been adopted by states and has not been reviewed by the FDA.
The agencies is also reviewing the way that it applies to drugs for cancer, diabetes, obesity and many other diseases, including cancer prevention and treatment.
The agency’s move toward limiting drug prices could have some unintended consequences, including an increased cost of prescriptions, said David Tatel, an economist at the Brookings Institution who has studied how pharmaceutical companies have changed pricing.
“There’s some concern that we’re going to be looking at a more aggressive approach in drug pricing,” said Tatel.
“We need to be mindful that the cost of drugs is not the only factor driving prices, and that it is not all of the cost,” he added.
The rules are also likely to impact the industry, with some experts suggesting that drug makers may seek to limit how many drugs can be on the market.
“They are not going to allow the prices to go up, but there are some other factors that we’ll be examining as well,” said Richard Vedder, an expert in health economics at the University of Minnesota.
The FDA’s rule, he added, is “the first step” in a plan to allow more drugs to be on sale at the same price as they were when the agency first adopted the guidelines in 2013.
Vedder said the rule would not have been so controversial if it were just an administrative measure, but that many other aspects of the drug industry are “being redefined.”
“The cost of this change will be a real challenge to the industry,” he said, because there will be some restrictions on what drugs can do and which companies can make them, and how many of them they can make.
The industry, however, says it’s confident that the rule will have no impact on the way it sells or charges drugs, and the price caps are likely merely a means to reduce costs and help keep prices down.
The Drug Enforcement Administration said the changes are necessary to prevent price gouging.
“While we do not yet have an official proposal for pricing changes, the agency anticipates a reduction in prices of between 10 and 25 percent,” said agency spokesman David Weldon in an e-mail.
“The FDA is working closely with industry partners and will continue to evaluate the impact of the FDA price-gouging regulations.”
The American Medical Association and the American Academy of Pediatrics have both weighed in on the issue, saying that the changes will help the industry keep prices in check.
The American Academy, a leading medical organization, has urged Congress to pass legislation that would prohibit drug makers from raising prices to avoid having to compete.
“It is our belief that prices should be set by doctors and patients to reflect the best available information,” the AAP said in a statement.
“When the FDA allows manufacturers to raise prices to meet the price-fixing demands of a few large pharmaceutical companies that benefit from their prices, it has the potential to cause prices to spiral out of control,” the AMA said.
The AAP and other organizations have argued that the FDA is ignoring the evidence that increases in drug prices cause more harm than good.
In a statement, the American Medical Society said it believes that the agency has been acting in the best interest of the American people, and it supports the goal of lowering the price for prescription drugs.
“If the FDA follows its stated goal of reducing the cost and increasing the quality of medicines, it will not see significant changes