Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the big news driving the industry this week.
In case you missed it
- Novartis fires counsel
- Oncology DTC ads are the latest fad
- CMS weighs national coverage for CAR-T
While we usually kick off Prescribed Reading with a look at deals and clinical data, there wasn't much M&A activity this week, and all the cancer data that has the market buzzing can be found in our roundup of ASCO abstracts. So let's take a look at the regulatory side, which had some major shake-ups this week.
Highly regulated
Last week ended with President Trump giving a rather vague speech about drug pricing that had many people scratching their heads and the markets celebrating by pushing drug stocks up.
Other branches of government and Trump's guys over at the Department of Health and Human Services spent the week clarifying the situation and insisting the actions had teeth.
Meanwhile, the Senate HELP Committee focused its attentions on the 340B Drug Pricing Program, looking for more transparency and oversight. The program was meant to lower drug prices for hospitals and their low income patients, but like many government programs, hasn't lived up to its fullest potential. The Senate and the President's 'American Patients First' blueprint are looking for more clarity on how hospitals are spending the savings.
At the same time, hospital lobbying groups are trying to shift the focus to drug manufacturers, suggesting high drug prices could be lowered at the source.
Over at the Food and Drug Administration, Commissioner Scott Gottlieb furthered his push to increase generic competition, calling out branded drugmakers that try to block generics from entering the market.
"There isn’t one single action that’s going to solve this issue. We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders. At the FDA, we’re taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability," said the Commissioner in a statement.
One such action from the FDA is a new website that shines light on the branded drugmakers abusing the system. Some pharmas use Risk Evaluation and Mitigation Strategy (REMS) programs or specialty distribution programs to keep samples out of the hands of generic drugmakers. The website highlights these drugmakers, including big names like Pfizer, Gilead Sciences, Celgene and GlaxoSmithKline.
While Gottlieb said the FDA wasn't looking to "shame" the manufacturers, it just might have that effect.
"In passing the 1984 Hatch-Waxman Amendments to the Federal Food, Drug & Cosmetic Act, Congress created a system that balances encouraging and rewarding medical innovation with facilitating robust and timely market competition," says the site. "Unfortunately, the process established by Congress may not always function as intended. At times, certain 'gaming' tactics have been used to delay generic competition."
The new FDA domain lists 52 drugs that the agency has received complaints about from generic drugmakers who were blocked from gaining samples. The list will be updated periodically.
The agency is also expected to shortly release new guidance aimed at addressing abuse of the REMS rules to allow generic manufacturers to use a non-shared REMS program when necessary to spur competition.
In another effort to shame drugmakers, the Centers for Medicare and Medicaid Services updated its drug pricing dashboard this week, calling attention to the drugs that have egregious price increases.
Critics of the moves say the actions don't actually lower drug prices and predict they will be ignored by companies.
The administration has notched some success in using media to target opponents and create public outrage over issues. Both HHS Secretary Alex Azar and Gottlieb have been particularly outspoken during their short terms in office.
It's too soon to say whether these tactics will work.
One early data point: Amgen gained an FDA approval for its closely watched migraine drug late Thursday, and announced it would be listed with a wholesale acquisition cost of $6,900 — well below the $10,000 analysts were projecting and a far cry from the $14,000 Amgen priced its cholesterol drug at.