The pharmaceuticals industry is no stranger to controversy.
Plagued with runaway drug prices that have drawn the ire of Americans, the industry has come under fire, most recently from Democratic presidential nominee Hillary Clinton.
But it’s not just the high cost of drugs that’s upset her.
It’s also the high cost of drug delivery systems.
Rising prices for EpiPens has resulted in outrage. When Mylan acquired the EpiPen from Merck in 2007, it sold for just $93 for a two-pack.
By 2013, the price had risen to $264 – a 184% price markup.
It’s now up to $600 – a 545% price increase in nine years.
Worse, other medication-delivery systems – such as the Advair Diskus fluticasone inhaler for asthma -- cost as much as $1,500 for a three-month supply.
Asthma, one of the most common chronic diseases that impacts about 40 million Americans – can usually be well controlled with medication.
But being able to afford such medications can be difficult.
“There’s no justification for these price hikes,” tweeted Clinton.
Although, the EpiPen maker has now offered coupons for $300 off a set of EpiPens, it still leaves the price higher than where it stood seven years ago.
Part of the reason for that is a lack of competition.
The EpiPen is essentially the only product on market at the moment with 93% market share and four patents on the auto-injector through September 2025.
It’s also been difficult to bring other products to market to compete.
Sanofi’s (SNY) Auvi-Q was recalled as recently as October 2015 over the potential for inaccurate dosage delivery.
The Adrenaclick product from Amedra Pharmaceuticals had a problem getting insurance companies on board and discontinued the product in 2012.
At one time, Teva Pharmaceuticals attempted to bring a generic version of the drug to market but was blocked by the FDA in February 2016. Regulators flagged “major deficiencies.”
However, Teva is now expected to submit its EpiPen Abbreviated New Drug Application (ANDA) by the end of this year. If cleared by the FDA, new competition could hit the market shortly after approval, helping to lower prices across the board.
The other problem has been higher deductible insurance policies, such as those under the Affordable Care Act that make such drugs costly, too.
In fact, while many patients are covered for major health events, they still get hit with the higher costs of medications if the drugs are not the formulary list of drugs – both generic and brand name – used by physicians to identify drugs that offer the greatest overall effectiveness.
For the estimated 3.6 million Americans who suffer from severe allergies that can result in life-threatening anaphylactic reactions, the price of an EpiPen has become outrageous.
While not every one affected by anaphylaxis will experience the same thing, the most common ailments can include hives, itching, swelling of the lips, and potential airway restriction that can result in tightness of the throat, chest tightness and difficulty breathing.
The treatment must be administered quickly, or death can result in as little as 30 minutes in worst-case scenarios.
Delaying a generic medication-delivery system that can dramatically reduce consumer costs is no longer acceptable.