After two days of sometimes tense arguments about whether the synthetic form of Vitamin D should be approved for use by people with high blood pressure, lung cancer patients and elderly patients with heart failure, the Federal Drug Administration approved the drug for adults this morning.
The panel of 13 regulators, drug company and medical community representatives voted 10-0 to approve the drug.
Before the vote, the FDA expressed dissatisfaction with the effectiveness of the drug, also known as an immunomodulator, in lowering blood pressure and many committee members described its efficacy as mixed.
Among the concerns the FDA had about the drug’s effectiveness and safety is that it is taken by many seniors with heart failure and high blood pressure and that could lead to heart attacks or strokes.
The company, CSL Behring, owns the drug. It touts the drug as a way to prevent diabetes-related cardiac events and has raised sales forecasts for 2018, but many experts have been disappointed with the company’s marketing campaign.
At one point the CEO openly questioned the balance of his company’s media strategy. “If you think about the messaging we’ve been using this whole time: ‘There are SALT builds: nutrition in, body out.’ So where is the balance? Where is the balance of our promotional efforts that are being put forth?” he said.
At another point during the panel session, many panel members and experts remarked that media hype is causing confusion about the drug and several questions arose about marketing of vitamin D supplements.
Advocates, who lined up in a row on the event floor of the FDA headquarters were satisfied with the outcome.