While Congress mulls a variety of drug pricing proposals and the Trump Administration reportedly finalizes an executive order, new FDA Commissioner Scott Gottlieb is introducing measures to tackle costs right away.
The FDA on Tuesday published a list of off-patent drugs with no competition—the document (PDF) is a staggering 10 pages long—and noted that, for many of them, the agency could immediately accept an application for generic approval "without prior discussion."
The agency also announced it’ll prioritize generic reviews for medications that have fewer than three competing products.
Both moves are designed to increase competition and ultimately lower costs. Off-patent drugs that have no generic competition face no pricing pressures; indeed, a host of them have been subject to large price hikes. It's no accident that one of the drugs on the FDA's generic hit list is Daraprim, the Turing Pharma med whose price went up by 5,000% two years ago at the behest of ex-CEO Martin Shkreli, touching off the drug-pricing controversy that continues to rage.
Also on the list are Pristiq, the Pfizer antidepressant and followup to Effexor; Johnson & Johnson's Elmiron, the only drug FDA-approved to treat the bladder condition interstitial cystitis; several chemo drugs; and meds that have hit the agency's list of shortages in recent years. The FDA figures the public list may incentivize generic drugmakers to develop copycats.
The second move could have a more immediate effect; by putting generic candidates with little competition at the front of its review line, the FDA could shepherd the new copycats to market relatively quickly. In formulating the policy, the agency reviewed data showing that consumers see real price relief several competitors are fighting for share. When only two generic products are on the market, discounts typically aren’t as high.
The FDA says the new strategies are early steps in a larger effort to tackle high costs, which Gottlieb announced in late May. At the time, the commissioner said the agency would also work to take on “gaming” of regulations by the industry that limit generic drugmakers’ ability to develop knockoffs.
The changes come at a time of high scrutiny on drug prices, but also as the industry breathes a sigh of relief on reports that President Donald Trump’s plans for an executive order aren’t particularly harmful to pharma's interests. After Trump said pharma was “getting away with murder,” back in January, some feared the worst.
Now, with news that the administration’s order will largely leave biopharma’s business model untouched—plus offer some tangible benefits such pursuing trade policies that protect pharma’s IP rights abroad—investor sentiment has improved. Critics recently blasted the administration for being too friendly to industry and Trump for breaking a promise.
In Congress, lawmakers are reviewing bills despised by the industry such as drug importation and Medicare price negotiations, though none has gained steam so far. Meanwhile, lawmakers in more than 30 states have introduced measures to take on the issue themselves.