FDA Plan for Generic Drug Names Gets Panned by FTC
With an estimated $60 billion worth of biotech drugs due to lose patent protection in 2016, the Food and Drug Administration is grappling with how it will review copycat versions of the products.
In the process, drug regulators are drawing fire from the government’s top consumer watchdog agency.
The Federal Trade Commission recommended in recent comments that the FDA reconsider its proposal for naming the generic medicines, also known as biosimilars, expressing concern that the proposal would hinder competition and keep prices high.
At issue are products derived from living systems such as cells that include some of the drug industry’s priciest treatments, including cancer drugs costing tens of thousands of dollars. Patient advocates and health insurers are eager for lower-cost generics to be introduced. However, the products are harder to replicate than synthetic drugs, because the manufacturing process involves living systems with inherent variations.
“Biosimilars are similar, they’re not the same,” said James C. Shehan, who advises health care clients at the Hyman, Phelps & McNamara law firm. “There’s going to be intense interest on seeing what happens when they’re put on the market. Is the safety and efficacy the same or different?”
The FDA has suggested that all biologic drugs have a nonproprietary common name and that the generic versions adopt that name along with a four-letter suffix to distinguish them from the originals and among themselves.
The FDA wants to distinguish between generics to let doctors and patients know a new biosimilar isn’t deemed a duplicate of the original drug.
But the FTC thinks this proposal goes too far.
“The FDA’s naming convention, which departs from the FDA tradition, may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition in biologic drug markets,” the FTC said last month.
Some fear the FDA proposal also may prevent pharmacists from swapping a cheaper generic for the brand-name original under state substitution laws.
While the FDA is constantly seeking comments on its many policies, the FTC does not often share its views so publicly. Since 1990, the FTC has only commented on two other FDA proposals.
The FDA proposed its naming convention in late August and the period for the public to comment closed last month. The 175 comments posted on Regulations.gov included reactions from the pharmaceutical industry, patient advocates, insurers and private citizens.
Big drug companies generally favor the FDA’s proposal while insurers and generic drugmakers echo the FTC’s concerns.
In its proposal, the FDA said the four-letter suffix could either be a random assortment of letters or four letters that have meaning, such as a shortened version of a manufacturer’s name. The only biosimilar approved for sale in the United States has the suffix “sndz” for the name of manufacturer Sandoz, a unit of Novartis International AG.
Drugmakers such as AbbVie Inc., Amgen Inc., Janssen Pharmaceutica, Merck & Co. Inc. and Pfizer Inc., along with PhRMA, the industry’s main trade association, generally agree the four letters should be meaningful.
“The use of a meaningful suffix might be more easily communicated by a company and recalled by a health care worker; if true, this would help support associations with, and trust within, a particular product,” Merck said in its comments.
On the other hand, those whose position aligns with the FTC suggest the FDA stick with International Nonproprietary Name standards, which is currently used with more common drugs — the INN for Tylenol and similar products, to cite one well-known example, is acetaminophen. The argument is that if each product has a different suffix, it effectively becomes a new name.
“Different INNs would likely reduce the impact of interchangeability by effectively exempting interchangeable biosimilars from state generic substitution laws, reducing savings substantially,” the seniors lobby AARP said.
In addition to concerns about costs, some say the proposal could create unmanageable complexity and potentially put consumers at risk.
“We are concerned that any unnecessary changes may interfere with current pharmacy safety alert systems used today,” drug giant CVS Health said.
It’s unclear how much weight the FTC’s comments will have. “The FTC position has a few potential holes that may lead FDA to discount it,” Shehan said in a blog post on his firm’s website. He said the data cited by the FTC supporting its position was limited. The FTC also cites an example from Europe where a biosimilar was less commercially successful when it had a different name, but Shehan said the name wasn’t the only explanation. “Dates of market entry, and the commercial savvy of different manufacturers” also had an impact, he said.
The debate over biosimilar naming is occurring at a time when the government is finalizing how it will regulate and pay for the drugs. Last week, the Centers for Medicare and Medicaid Services said it will consider copies of biotech products as a group in setting reimbursement rates, disappointing drugmakers who wanted the follow-on versions considered individually.
The FDA is still working on guidance about how it will evaluate whether biosimilars can be considered interchangeable with the original drugs. In the European Union, where all generic biologics share a nonproprietary name with the original drugs, biosimilars have been in wide use since 2006.
At a hearing in September, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told senators on the Health, Education, Labor and Pensions subcommittee she hoped to release policy drafts by early 2016, but couldn’t commit to specific timelines. She also addressed the FDA’s thinking about naming the new products.
“There are tradeoffs involved in various labeling decisions,” Woodcock said. “We need to have a labeling convention that maintains the trust of clinicians who want to understand what their patients are getting.”