Controversy continues over the pricing of the EpiPen auto-injector, even as its manufacturer announced several measures aimed at increasing access to the device.
In 2004, pricing for a package of two auto-injectors stood at about $100 (in 2016 dollars to adjust for inflation), but the price of the anaphylaxis treatment has , prompting a by patients and families to try to get Mylan, the maker of the EpiPen, to cut the price. Several critics have noted that the included in the auto-injector is about $1.
Mylan has responded in several ways, including with what it called a "zero-pay" card that cuts co-pays deeply for those with good insurance, but only reduces the cost by about $100 for those with high deductibles or who are uninsured.
On Aug. 29th, the company announced that it would come out with its own generic version of the EpiPen. "We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public's desire to ensure that this important product be accessible to anyone who needs it," Mylan CEO Heather Bresch posted on the company's website.
"Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response, which required the cooperation of our partner. However, because of the complexity and opaqueness of today's branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high-deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option."
Experts Skeptical
The company's allusion to the drug supply chain and health insurance companies as part of the reason for the price hikes doesn't sit well with many observers. "I don't find it terribly legitimate because it's not clear to me how different that is than in the past," said , a patent law expert and professor of law at Emory University, in Atlanta, in a phone interview.
"Maybe the Affordable Care Act created this dynamic in some way -- that may explain some pressure on the price but I don't think it explains that significant of a jump."
Mylan's decision to come out with its own generic is not necessarily that unique, Holbrook noted. "It is fairly common for a brand drug to make what's called an authorized generic when other generics are entering or already in the market. They can charge a higher price for the branded drug, and then enter the generic market and compete with other generics [too]."
What is unusual, however, "is that Mylan is creating an authorized generic in the absence of generic competition," he added. "It sounds like a good PR move -- it might be -- and it might be [a way to] head off other generics."
Price hikes like this one are just a symptom of a larger problem, according to , president-elect of the American Academy of Family Physicians. "We are seeing way too many examples of drugs with almost a monopoly on production and prices are just sort of out of control," he said in a phone interview. "It's very difficult for a patient to be able to spend $500 for a medication, especially when we're talking about medications we know to be reasonably cheap."
Physician Groups Respond
Physician groups have generally been critical of the price increase, although in varying degrees.
American Medical Association (AMA): It urged Mylan to "do all it can" to rein in the price. "With many parents required to buy two or more sets of EpiPens just to keep their children safe, the high cost of these devices may either keep them out of reach of people in need or force some families to choose between EpiPens and other essentials," AMA president , said in a statement
American Academy of Pediatrics (AAP): The group said it "is gravely concerned some families will be left without access to this important medication," AAP president , said in a statement. "Urgent solutions are needed. Now is the time for all interested stakeholders -- families, doctors, manufacturers, distributors, payers and government agencies like the Food and Drug Administration -- to act quickly to alleviate the financial hardships faced by families.
American Academy of Allergy, Asthma & Immunology (AAAAI): It took a more conciliatory tack. "The AAAAI welcomes the announcement from Mylan ... that they will soon have a generic epinephrine autoinjector available at a lower cost (approximately $300 for a two-pack) than EpiPen," said AAAAI executive vice president , in a . "We implore all parties involved with the manufacturing, approval and distribution of this alternative, as well as any other equivalent product in development, to make it available as soon as possible. Improving patient outcomes requires this shared commitment to patient access."
Congress Jumps Into the Fray
Members of Congress also are getting involved. "We would like more information to understand Mylan's pricing of its EpiPen and how the company is ensuring that patients suffering from allergic emergencies have access to these life-saving products," Democratic members of the House Energy and Commerce Committee wrote in a . "Further, please explain why Mylan chose to authorize a generic product versus reducing the cost of its brand-name EpiPen."
The Democrats -- including (D-N.J.), the committee's ranking member, also called on committee chairman (R-Mich.) to hold a hearing in September on the issue. For their part, committee Republicans sent a to FDA commissioner , noting that they were "concerned about the lack of generic competition in the epinephrine auto-injector market" and asking the FDA to answer a list of questions about the approval process related to the EpiPen and its competitors.
Another letter to Mylan emanated from the House Oversight and Government Reform Committee -- signed by both the Republican chairman and the ranking Democrat -- related to EpiPen pricing.
Over in the Senate, a group of 20 Democratic senators led by (D-Mass.) sent a seeking detailed information on the EpiPen market as well as the company's program to provide free EpiPens to schools.
"The EpiPen ... has become so exorbitantly expensive that access to this life-saving combination product is in jeopardy for many Americans," the senators wrote, adding that the company's discount coupons and other programs amounted to a "complex shell game ... When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government, and employers still bear the burden of these excessive prices."
(R-Iowa), chairman of the Senate Judiciary Committee, asking similar questions, saying he was concerned the price increase could limit access to the medication.
Consumer advocacy group Public Citizen also got into the act, delivering on Aug. 30th a signed by more than 700,000 people to Mylan's headquarters near Pittsburgh. The petition demanded an immediate reduction in the price of EpiPens. "We are here today because of corporate greed," Rick Claypool, a researcher at Public Citizen, said during the petition event, noting that the company makes $1 billion a year from EpiPens alone.
The issue even spilled over into presidential politics, with Democratic candidate Hillary Clinton on Friday to deal with price-gouging in the prescription drug market. The plan calls for consumer oversight at public health agencies and agencies that regulate market competition; oversight would include determining what constitutes "unjustified, outlier" drug price increases and levying financial penalties on companies who raise prices to those levels.
As a company, Mylan is no stranger to controversy. The company took heat in 2014 when it -- a plan to move its official headquarters to the Netherlands in order to lower its tax burden. And the $19 million compensation package for Bresch, the daughter of (D-W.Va.), has . (Manchin to review Mylan's response to the EpiPen controversy and expressed alarm at the product's price increases.)
Bresch came under fire herself in 2008 for from West Virginia University, in a scandal that eventually and several other top officials.
Mylan did not respond to a request for comment on this story.