In a policy change (pdf) authored by recently appointed FDA Commissioner Scott Gottlieb, the agency will now fast-track applications for generic drugs until three of them have been approved for a given medication.
And in a transmission to manufacturers about what it’s looking for, the FDA also published a list (pdf) of about 170 categories of old drugs without generics, ranging from a glaucoma drug to the penicillin antibiotic amoxicillin.
Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic drug industry group, known as the Association of Accessible Medicines, praised the move alongside other industry experts.
The shift follows the release of an amendment attached to the Senate user fee reauthorization bill that would have made a similar change to the prioritization of generics.
And for an FDA commissioner once criticized for his close ties to industry, Scott Gottlieb has now taken steps to directly address US drug prices that none of his predecessors took. In fact, the agency has previously tried to avoid the politics of pharmaceutical pricing and stick to matters concerning the efficacy and safety of drugs, notes the journal Regulatory Affairs Professionals Society.
Gottlieb said in a statement Tuesday: “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require.”
In a contrasting stance, Guido Rasi, executive director of the European Medicines Agency, last week told attendees of the Drug Information Association’s (DIA) annual conference in Chicago that he wanted to keep the decision of pricing separate from the agency’s assessments of benefits and risks.
“Generic products for which there are fewer than three ANDAs approved for the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD may receive expedited review.”
Last week, FDA also issued draft guidance for sponsors on how they can qualify for these reviews that are two months shorter than other reviews of ANDAs.
The update builds on the MAPP’s most recent update from March 2016, when FDA said it would prioritize ANDAs when there is only one competitor.
FDA also on Tuesday released two lists of drugs, each of which contain more than 100 active ingredients, including one “for which FDA could immediately accept an ANDA without prior discussion,” and the second for drugs “involving potential legal, regulatory, or scientific issues which should be addressed with the Agency prior to submission of an ANDA.”
The first list includes some drugs that made headlines because their prices have spiked in recent years, like Turing Pharmaceuticals’ toxoplasmosis treatment Daraprim (pyrimethamine) and Valeant Pharmaceuticals’ Wilson’s disease treatment Cuprimine (penicillamine).
Others listed include J&J subsidiary Actelion Pharmaceuticals’ pulmonary artery hypertension drug Tracleer (bosentan) and two Bristol-Myers Squibb chemotherapies: Lysodren (mitotane) and Vumon (teniposide).
The second list includes the epilepsy treatment Peganone (ethotoin), first approved by FDA in 1957, the leprosy treatment no longer available in the US, known as Lamprene (clofazimine), which was first approved by FDA in 1986, Eisai’s ovarian cancer treatment Hexalen (altretamine), which first won FDA approval in 1990, and AbbVie’s respiratory distress syndrome treatment for infants Survanta (beractant), which first won approval in 1991.
The lists of active ingredients that lack generic competition will be updated every six months, FDA says.
“We intend to develop it into a list of individual NDA drug products that lack competition,” FDA adds, noting that new drugs approved in the last year have been excluded.
On 18 July, FDA will also hold a public meeting to discuss finding a balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost generics.
In testimony before the House appropriations subcommittee May 25, 2017, the new commissioner, Dr. Scott Gottlieb, highlighted several methods that could prevent biopharma companies from gaming the system, focusing specifically on “situations where off-patent drugs lack an approved generic competitor.”
Gottlieb declared he would get the FDA to publish a list of drugs that are off patent “for which FDA has not approved a single generic applicant.”
Gottlieb wanted to flag the potential for a repeat of Martin Shkreli’s decision to buy an old generic, Daraprim, and then raising the price of the drug overnight by more than 5000% at his company, Turing. Daraprim had no generic competition on the market, giving Shkreli a clear and legal path to inflating the price, says Endpoints.
Dr. Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies.
“We do have situations where speculators, for lack of a better word, can come in and buy a low volume generic, jack up the price knowing that it will take potentially years for generic competition to come on to the market so they have that sort of an exclusivity period,” said the commissioner.
Gottlieb, who previously served as deputy commissioner of the agency under former President George W. Bush, has held a number of roles in the industry, including serving as a director or advisor for drugmakers including GlaxoSmithKline , Bristol-Myers Squibb and Vertex Pharmaceuticals.
During nomination hearings, Democratic lawmakers questioned whether Gottlieb’s ties to industry would affect his ability to independently lead the agency. Such concerns are now rapidly evaporating.Steve's Take: Concerns of @ScottGottliebMD ties to big #Pharma are rapidly evaporating Click To Tweet
A resident fellow with the conservative American Enterprise Institute, Gottlieb has a long written record of articles, speeches, and congressional testimony that lay out his vision and explain his priorities; a welcome example of transparency in marked contrast to the daily rancor and partisan bickering on Capitol Hill.
He “sounds like a progressive person who wants to get things done,” said Eli Lilly & Co. Chief Executive David Ricks in an interview. “He’s got experience in the agency already. He’s a doctor and a cancer survivor. Sounds to me like he has a balanced perspective.”
Wisely, Gottlieb has remained mum on the GOP’s health-reform plan.
I’ve said it before, but if President Trump is savvy with this solid appointee, he’ll let Gottlieb run the show at FDA and approach the drug pricing issue without interference and any coaxing from the White House. Qualifications-wise, he’s got what it takes to do an excellent job leading the agency to serve its public purpose.
Now, with this program for speeding new generics to market, we also know that Gottlieb follows through, and actually does what he says he’ll do what he says he’ll do. Take note, politicians and government officials at large.