The anger over EpiPen's 400 percent price spike may be giving some people deja vu.
But the outrage directed at the maker of the allergy treatment, Mylan Pharmaceuticals, may be partially misplaced, as experts say that the federal government should shoulder more of the blame.
EpiPen is a generic drug, and a major reason why the price rose 400 percent since Mylan acquired it in 2007 is because the drug has no competition.
"The question in my view is why do they have a monopoly," asked Scott Gottlieb, a physician and resident fellow at the right-leaning American Enterprise Institute.
In the EpiPen's case, three generic drugs are coming to the market that would create competition. However, inherent flaws in the Food and Drug Administration's approval of generic drugs is hindering quick approval of any competitors, Gottlieb told the Washington Examiner.
Gottlieb noted in an article for the think tank that generic drugs were intended to get to the public easily to ensure competition with pricier name-brand products. Since generics were a copycat of a brand drug, it didn't have to go through the same rigorous approval process.
He said the Food and Drug Administration has pushed for generic drugmakers to shoulder the same burdens as brand-name manufacturers.
"For example, in a push to reduce the risk of contamination, the agency in 2009 forced generic drugmakers to retool their sterile manufacturing plants and make production lines less intricate," Gottlieb wrote. "The abruptness of the change caused many facilities to be shut down, creating drug shortages and driving up prices."
He added that the cost of applying for approval of a generic drug has soared, from about $1 million in 2003 to up to $10 million now.
A major problem is the FDA is too stringent in its review of complex drugs such as the EpiPen, which has a needle injector.
The EpiPen has to be the exact same as a brand-name drug, but the syringes may differ slightly from generic competitor to competitor.
"If I give you this EpiPen syringe and another company comes in with their syringe, the label can't be exactly the same because the syringe will be slightly different," Gottlieb said.
He called for the creation of a new pathway that generic makers could use to get quicker approval of complex products.
"Right now the pathway was designed for pills that are easy to copy," he said.
A new pathway could allow generic makers to submit a drug application that is slightly different than the brand-name product, but not different in a way that has a health impact, Gottlieb said.
Pressure is already increasing on the FDA to approve an EpiPen competitor. Generic drug giant Teva Pharmaceuticals has filed an application, but it has been delayed due to concerns from the agency.
A group of bipartisan senators are concerned about the lack of competition and wrote to the FDA earlier this week to ask if "any barriers exist to the approval of safe alternative products to the EpiPen."
The senators also want the FDA to answer if there are any instances that warrant changes "to the typical FDA approval timeline, such as drug shortages, and the nature of any resource constraints you face in ensuring timely approvals."
Other experts say the FDA is in a tough spot as it traditionally doesn't take into account price when making approval decisions.
Whenever the agency has prioritized one application above another for regulatory approval, essentially jumping to the front of the line, it is because it is a clinical breakthrough.
"But for a number of cases, there is a strong economic argument to jump the queue when there is no competition," said Gerard Anderson, a professor at Johns Hopkins Bloomberg School of Public Health.
Anderson noted the federal government can make some other moves to ensure greater generic competition, but not from the FDA.
Congress could signal to the Federal Trade Commission to not approve more mergers of generic drug companies. He cited the merger of generic drug giants Teva and Allergan.
"When there are mergers and acquisitions and consolidations, there is no robust competition," Anderson said.
However, even considering mergers, the time it takes to approve a generic drug is still too long, wrote Timothy Holbrook, a law professor at Emory University, in an article for the website The Conversation.
"It may be time for the FDA to reconsider some of its regulations governing these well-known, generic drugs to reduce the cost of approval and to facilitate competition," he wrote. "For example, the FDA may need to consider some sort of accelerated approval for importing drugs already sold in countries with regulatory systems comparable to our own."
The FDA already eases approval of some imports if it is to alleviate a drug shortage.
Little to nothing has been done in Congress on drug prices, despite concerns from both sides of the aisle.
Hillary Clinton has pushed a plan that addresses drug prices that would allow Medicare to negotiate for higher prices, which is currently forbidden under federal law. GOP nominee Donald Trump also has said he likes the idea of Medicare negotiations.