CHICAGO -- , stepped up to the mic, pulled a pill out of his pocket -- a new, extended release formulation of an irritable bowel syndrome (IBS) drug that costs $10.75 a dose -- twisted open the opaque capsule and poured out a single tablet, which was the old "formulation" that had cost just pennies when it was on the market.
Kennett, a member of the Council on Legislation, and a delegate for the American College of Cardiology, isn't happy with these surges. "This lowers medication compliance. Patients still have to take this new 'formulation' six times a day," he said in an interview with 51˶.
Here at the , the House of Delegates rolled five resolutions aimed at curbing addressing skyrocketing generic drug prices into one new policy that directs the AMA to seek help from the FDA, Federal Trade Commission, and the Generic Pharmaceutical Association, and to "encourage the development of methods that increase choice and competition in the development and pricing of generic prescription drugs."
Insurance & PBMs
Solutions, several doctors argued, won't be easy because there is too much money on the table.
"PBMs [pharmacy benefits managers] don't lose in this situation," , a Georgia delegate said. "I'll give you an example: lisinopril for 1,000 [mg] has doubled from $507.50 to $1,053 in 5 years."
Antalis also referenced doxycycline, an antibiotic that went from $70 for 50 capsules to $276. "They're taking money from healthcare plans, taking money from patients, more importantly."
Another delegate said his own blood pressure medication jumping 370% in 1 year. "I don't know what the effect would be on a person who is on 10 or 15 medications."
"Some health plans are requiring prior authorization for generics," a delegate from the American Academy of Family Physicians said.
"I had a patient just a week ago, who waited 3-4 years for aripiprazole to go off patent to get the generic, and I got a call from the patient at the pharmacy that the generic cost more than the brand name," he said.
A third delegate said he'd spoken to the vice president of a major pharmaceutical company on the phone. When asked about a price increase in an insulin drug, the VP simply stated that if patients were feeling that increase, "they didn't have a good enough insurance policy."
Mergers and Acquisitions
"With some very important cardiovascular drugs, there's just egregious raising of prices," Steven Hao, MD, speaking on behalf of the cardiovascular section. "And just because of market share, not due to any problems with manufacturing the drug or supply."
"Isoproterenol was made by Hospira, the only U.S. manufacturer, and was $44 per dose in 2013. ," Hao said.
Hao noted that this incident led to a Congressional inquiry, spearheaded by Senator Bernie Sanders.
When called to testify before the Subcommittee, Marathon Pharmaceuticals refused and subsequently sold the drug to Valeant Pharmaceuticals. According to Hao, this sale shot the drug price up to $1,200 per dose on the day of sale. "This is gross misuse of our free market, and it's impacting the quality of care, access to care, and our ability to take care of patients."
Surge & Shortage
"The biggest outrage is phenylephrine," , a New Jersey delegate, said. Phenylephrine is a liquid used in dilation, which, Cinotti said, ran less than $10 for a 15 mL bottle when he started practicing, and only crept to $15 per bottle in 2014.
Cinotti claimed that a pharmaceutical company discovered that the drug didn't have a National Drug Code (NDC) number. This can happens to prescriptions in existence prior to the creation of the FDA. "In their application, they used literature from the 1970s, no research, no added expense to them ... they got an NDC, and the price today is $115 per bottle."
According to Cinotti, all of the other generic manufacturers stopped producing the drug, leaving one manufacturer in Turkey. on the drug shortage list in April 2015.
Cinotti suggested federal subsidies under the orphan drug program be used to stabilize the price.
Big Pharma
, from the Council on Science and Public Health, pressed an AMA reference committee to support the resolutions. Testifying, "I don't think we need studies. In 2013, the Council produced a very nice paper that describes all the reasons why prices are rising ... The reason, quite simply, is greed on the part of pharmaceutical companies.
The wake-up call for me was this year when I had to start doing prior [authorizations] for digoxin," Motta said.
According to Motta, the New England Journal of Medicine published information about the base compounds in digoxin in their first issue. "And here it is, 203 years later, and I have to do a prior auth for something that was made as a tea 203 years ago."
In the last 4 years, according to Motta, the price of the drug increased from about $4 to $180 for generic.
"More than 50% of patients don't take medications as prescribed due to cost, and 22% don't take their medications at all because of cost," Motta referenced a 2014 paper in the New England Journal of Medicine.
Motta's resolution suggests waiving fees for generic drug makers to enter the market thereby encouraging competition in the marketplace.
"They [pharma] are not uniquely greedy. They are exercising their greed in a unique market. The problem is also on the buy side," Richard B. Warner, MD, of Kansas, said. "People are buying prescriptions with un-real money, with insurance benefits rather than with real dollars."
"You have a mechanism where the seller sets a fictitiously high price. You have a total distortion of a normal market where people pay real things. We need to pay attention to last dollar responsibility."
David M. McKalip, MD, from the Florida delegation brought up the role of the FDA in creating shortages in injectable drugs. "Their attempts at excessive regulation led to companies stopping to produce." McKalip cautioned his fellow delegates against over-regulation of the pharma industry, which might induce more shortages.
However, he said, government created monopolies should be regulated against. "If crony corporations are using the power of government to drive out the competition, that can certainly drive up prices."