Gottlieb in a fireside chat at BIO 2018.
What can the biopharma industry expect from the Food and Drug Administration in 2019? A flurry of guidance documents, for one.
But through those documents, the agency has plans in store to promote competition among pharmaceutical and biologic products, FDA Commissioner Scott Gottlieb said in a fireside chat at the J.P. Morgan Healthcare Conference in San Francisco. Gottlieb spoke remotely with J.P. Morgan senior healthcare analysts Cory Kasimov and Chris Schott.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Gottlieb emphasized that he did not see the FDA has having a role in regulating drugs’ cost effectiveness. “I don’t think we should have a specific mandate to do that,” he said. “I think the market has enough levers and leverage to prescribe what they think is a cost-effective therapy in different setttings.”
However, generic competition is one area in which the agency plans to be active this year.
One area of focus will be on complex generic drugs, meaning generic versions of drugs that, while no longer protected by patents or exclusivity, have certain features that make “generalizing” them more difficult, such as complex injectables and asthma inhalers. Gottlieb said the agency expects to put out a guidance document “soon” that will outline new parameters for companies to go through the Abbreviated New Drug Application process – or ANDA, the approval process for generics – with a complex generic process.
In addition, Gottlieb said, in conjunction with the Patent and Trademark Office, the FDA will be taking an unusually close look at the Orange Book – which lists patent and exclusivity information for pharmaceutical drugs – and in particular at things that should be patented and aren’t, or that are patented and shouldn’t be. That particularly applies, he said, to patents that are determined not to serve the interest of public health, but to thwart competition. Overall, the number of generic launches has not matched generic approvals. “One of my growing concerns, we’re approving a lot of drugs, but not seeing a commensurate number of drugs launched,” he said. So the agency is “looking how we can facilitate more generic drug launches, not just approvals.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In October, the agency saw a record number of generic approvals – 110 for the month, along with 18 tentative approvals. The figure included 17 complex generics and 23 drugs that were the first generic versions of branded products.
On the biosimilars front, another guidance will tackle the issue of interchangeability, meaning the ability to substitute a biosimilar for the reference biologic the same way a generic can be substituted for the novel pharmaceutical. While saying that the had foreseen biosimilars as facing a “slow ramp” – much as generic drugs did after the 1984 passage of the Hatch-Waxman Act that formally created a regulatory approval pathway for them – Gottlieb expressed concern about the potential for failed biosimilar launches discouraging other companies from entering the market. One reason it is difficult to penetrate the market, he added, is that even if a biosimilar is priced below the reference biologic, there may be rebates in place that give the reference product an advantage. The agency also plans to simplify and enable electronic access to the Purple Book, which lists patent and exclusivity information for biologics.
As of December, 16 biosimilars have received FDA approval, according to list on the agency’s website. Most recently, in December, the agency approved Celltrion and Teva Pharmaceutical Industries’ Herzuma, a biosimilar of Roche’s Herceptin (trastuzumab). In November, it approved the same two companies’ Truxima, the first approved biosimilar to Roche’s Rituxan (rituximab), albeit with a narrower label than the reference product.
Efforts to encourage competition among branded drugs are in the works as well. An analysis the agency will soon release shows that the time for second-in-class drugs to reach the market after first-in-class drugs has grown longer, to the point where first-in-class drugs are often the only products available. The problems that arise from having only one drug in a given class on the market extend beyond price too, he said. Some patients may not be able to respond to that drug, and having multiple products may be the only way for them to benefit from therapy. Thus, he said, when companies or venture capital firms pull out for fear of a product being third to market, it’s concerning from a public health perspective. “If companies and venture capitalists are pulling out because they fear being third to market, that’s concerning from public health standpoint.”
Photo: Alaric DeArment, MedCity News
