Gottlieb: “we’re not going to play regulatory whack-a-mole”

In last week’s He said, she said InsightCity article we talked about how regulators in Britain don’t think the price of biosimilar products is low enough. FDA Commissioner Scott Gottlieb has kicked it up a bit. In prepared remarks, Gottlieb blasts the pharma industry. Some quotes: “the FDA approved 11 biosimilars, only 3 are marketed in the U.S.” – “competition is, for the most part, anemic.” – “if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017.” – “branded drug makers thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry.” All this was part of FDA releasing their Biosimilars Action Plan and the final guidance on biosimilar labeling. Might be time to keep your head down.

Real-Time Oncology Review

Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.

Important imports?

The Department of Health and Human Services has directed the FDA to consider the importation of foreign drugs to address price spikes. The proposed policy would only apply to drugs unaffected by patent or exclusivity, in an effort to avoid intellectual property issues. However, pharma companies may still have something to say through their lawyers if such a policy were to be implemented, especially as an act of a federal agency instead of legislation. If it were implemented though, it would avoid patient access issues in situations like when an HIV medication jumped in price from $13.50 to $750, which had the incredibly unfortunate side effect of catapulting Martin Shkreli’s infinitely punchable face into the limelight. That drug still costs $750 by the way. Or just 5-10 cents in India.

FDA and digital health, a marriage…

… “in the making” might be the best way to describe the relationship. On one side, the FDA has recently approved 14 new digital health products. On the other side, recent FDA guidance leads Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law to say, “Industry wants faster approvals. FDA wants more control over industry. So, FDA’s proposing an exchange: faster approvals for more FDA authority.” All this hullabaloo centers on whether FDA should certify every digital health product or can they certify digital health at the company level. We don’t know. What we do know is that digital health is hot, really hot, like there’s been $1.62B invested in digital health companies in Q1 2018. That’s $18M per day. Per day! Prefer smaller numbers? It’s $12,500 per minute. Muy caliente.

Everyone’s getting the short stick

Drug shortages are nothing new, that’s why the FDA updates their list of shortages daily. But things seem a little worse than normal—9 in 10 physicians say their emergency departments lack critical medicines. That includes mainstays like diltiazem (a go-to treatment for hypertension) and morphine. You can blame market forces and manufacturing issues. Most of the drugs in shortage are sterile injectables, which can be difficult to both make and make a profit on. Those low margins can lead to less incentive to maintain the quality of sterile injectable manufacturing facilities as they age, which in turn leads to issues with the quality of the drug products. It’s things like that which can cause cardboard to contaminate batches of “sterile” injectables. If only they had contaminated them with cash instead…

Right to try, is it alright?

The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”

Drug manufacturing is easy, not

Just ask Pfizer. This week Pfizer ran into a couple “issues” surrounding drug manufacturing. Ok, to be honest, Tris Pharm—a CMO—was issued the FDA warning letter, but it was for a Pfizer ADHD product (Quillivant XR) and Pfizer was named in the FDA letter. This is also not just an issue for Pfizer, but for patients. For example, 6.1% of American children are on ADHD medication. To add insult to injury, Quillivant was recently listed as a drug that is in short supply. Our advice, stock up on Quillivant. Also this week, the FDA released a Complete Response Letter (CRL) for the company’s proposed trastuzumab biosimilar. Using normal words; no soup for you as the FDA highlighted the need for additional technical information and does not relate to safety or clinical data submitted in the application. Hopefully next week will be better.

Scott scorns shenanigans

Listen up, innovators. FDA head Scott Gottlieb is sick of your games (live footage here.) Specifically, he’s sick of companies that won’t provide samples of their products to generic producers, which slows down their research into developing a cheaper alternative. This essentially boils down to a non-patent-based approach to maintaining market exclusivity, and it looks like it won’t be tolerated for much longer. Not only is the FDA sounding off on the practice, but so is the FTC and even Congress. Innovators argue that regulation isn’t needed, considering the FDA approved a record number of 1,027 generics last year. The agency shot back saying it’s received over 150 inquiries from generic companies who couldn’t get the samples they needed. So what is the truth?