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FDA Just Approved the World’s Most Expensive Drug

FDA Just Approved the World’s Most Expensive Drug
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…that will cost $2.1 million.

The Food and Drug Administration (FDA) recently approved a gene therapy drug for a form of spinal muscular atrophy (SMA). Novartis is pricing the drug, Zolgensma, at $2.125 million, or $425,000 per year for five years.

The drug is meant to treat children under 2 years of age with SMA, an inherited disease that, in its most severe form, can cause infants to die or require permanent breathing support.

Novartis faces competition from Biogen for an SMA gene therapy drug. Biogen’s product, Spinraza, was approved in 2016 and also comes with an eye-catching price tag. Spinraza requires regular spinal infusions that cost $750,000 in the first year, then $375,000 per year thereafter.

Novartis noted that it is working with insurers to implement pay-over-time and other schemes to help patients get the drug.

This is par for the course for Big Pharma and our crony medical system. Many blockbuster drugs will soon be off-patent and open to generic competition. Drug companies have also had difficulty developing new drugs. To make sure profits don’t suffer, Big Pharma is focusing on developing expensive drugs for rare diseases that can get expedited approval through the FDA’s orphan drug program. Orphan drug designation gets drug companies prolonged market exclusivity, waived FDA fees, and tax credits on their research and development costs. Big Pharma can then charge exorbitant prices for the drug, justifying the high price because targeted disease affects so few people.

Recall, too, that the FDA has allowed drug companies to steal natural substances and turn those into expensive drugs. CBD oil has been available in supplement form for years, but the FDA just approved a CBD drug for a rare form of childhood epilepsy that will cost $32,500 a year. L-glutamine can be purchased for $10 dollars a bottle, but the FDA approved an L-glutamine drug that will cost $40,000 a year. In both cases, the drug company can petition the FDA to remove the supplement version from the market, eliminating competition that could provide consumers access to an affordable option for these natural substances.

It’s no secret that healthcare is a disaster in this country, with skyrocketing medical costs. We can’t hope to address these spiraling costs if we keep taking cheap, safe, and effective natural medicines and turning them into expensive drugs.

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