Pharmaceutical pricing has long been a contentious issue. Research is undeniably expensive and shareholders need their pound of flesh too, but are recent price hikes pushing the ethical boundaries? What better time for the FDA to carry out its study into the relative effectiveness of generic drugs and their branded counterparts.
The issue of drug pricing has come to a head. The US price of branded oncology drugs has doubled in the last decade to around $10,000 a month – leading to what Bloomberg described yesterday as “a drug-cost revolt” among doctors and insurers.
This story comes hot on the heels of others about the impending launch of the world’s first million dollar drug. Bloomberg even produced a rather fancy infographic that lets you see what has happened to the cost of 73 US drugs whose prices rose by 75% or more over the last seven years. It would have been nice to see a non-cherry-picked version representing average price hikes but you can’t have everything.
Perhaps it isn’t surprising then that generics account for 80% of US prescriptions. But its human nature to question whether the plain boxed no-name pill is as good as the one with the brand recognition.
US Federal law is quite clear on the matter. Companies looking to launch generic versions of approved drugs must show that their products are the same as the branded drug in terms of:
- active ingredients
- dosage form
- route of administration, and
- label.
“In addition, the company must demonstrate that the generic form is absorbed and distributed to the part of the body at which it has its effect at acceptably similar levels to the brand name drug. And all drugs—new or generic, in clinical trials or approved, prescription or over-the-counter—must be manufactured under controlled conditions that assure product quality.” Says the FDA website.
The FDA recently launched a programme to test just these assertions. This will be the first time the agency has possessed the resources to carry out widespread checks on the quality and efficacy of generics. They will start with generic heart drugs, ADHD treatments, immune suppressants, anti-seizure medicines and antidepressants.
One of the first groups of drugs to be examined are extended release generic blood pressure medicines, mostly copies of AstraZeneca's extended release Toprol XL (metoprolol succinate).
Generic metoprolol succinate is sold in the US by Mylan, Actavis, Dr Reddy's Laboratories and Wockhardt. Together, these account for 90% of the 40 million US prescriptions for the drug.
The waters are further muddied because many of the generics sold in the US originated in India. Despite a recent campaign to strengthen the image of India as a producer of high-quality, low-cost drugs, recent FDA warnings and bans have left a serious dent in its reputation.
Toprol XL is absent from the list of drugs whose price rose more than 75% in the last seven years.
Maybe you DO get what you pay for?
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