Despite complaints about its drug approval process, the FDA nevertheless is a necessary part of the pharmaceutical industry. As of now, the oversight process takes a long time, primarily because the FDA is underfunded, which results in a backlog of to-be-vetted applications.
Therefore, if we want the FDA to run more efficiently, we must first give it the resources to do so. With the funds necessary to speed up its approval process, the FDA could then help new drugs could be brought to market faster, thereby reducing Mylan-esque monopolies. These two solutions are not novel, and they are also not enough. The Mylan case will neither be the first, nor the last, time that a drug manufacturer uses its monopoly power to hike up prices to unreasonable amounts.
If we hope to see long-lasting, impactful transformation of the pharmaceutical industry, then we will need some voluntary or legislative drug price regulation. President Obama has already supported legislative action to increase transparency of drug development costs, increase rebates from manufacturers for certain Medicare and Medicaid beneficiaries, and give the federal government authority to negotiate prices for expensive pharmaceuticals.
Such legislation would be a powerful step in the right direction, and would begin to disassemble the drug monopolies we see today. Unfortunately, federal intrusion into the pharmaceutical industry remains unpopular among many interest groups, including pharmaceutical companies. Ezekiel J. Emanuel and Emily Gudbranson contributed to this article.
Emanuel is vice provost for global initiatives, Diane v. Levy and Robert M. Where the most influential players in business and beyond…. Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness and access to treatment for those living with potentially life-threatening severe allergies. Ensuring access to epinephrine — the only first-line treatment for anaphylaxis — is a core part of our mission.
With changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high deductible health plans, and deductible amounts continue to rise. This shift has presented new challenges for consumers, and they are bearing more of the cost. This change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve.
This is a BETA experience. You may opt-out by clicking here. More From Forbes. Jul 31, , am EDT. Jul 24, , pm EDT. Jul 10, , am EDT. Jul 9, , am EDT. Jul 7, , pm EDT. Jul 6, , pm EDT. Edit Story. Aug 21, , am EDT. That, in turn, led to the list price of EpiPen being artificially inflated, Berman said. Mylan is the only named defendant in the suit.
But the suit also claims that CVS Caremark, Express Scripts and Optum Rx participated in the scheme, "sharing the common purpose of inflating the list price of EpiPen, through a pattern of racketeering activity. The PBMs, the suit alleged, "knowingly made material misstatements to health care payers, plan members, and the general public" about the actual price of EpiPen, the extent to which the published price differed from the actual price, and the extent to which they and Mylan "negotiated the rebates discounting the list price of EpiPen for a purpose other than the PBMs' own enrichment.
The trade group representing PBMs, the Pharmaceutical Care Management Association, said in a statement to CNBC that: "Mylan has spent the past year blaming Washington, the prescription drug supply chain, and competitors for its unusual pricing practices.
It's time for them to look in the mirror and take responsibility for their own actions.
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