AUGUSTA — The Legislature will soon consider a proposal that claims it will reduce drug prices for Maine consumers. The debate promises to highlight conflicting ideas, views and opinions of the pharmaceutical industry as our legislative colleagues try to decide the fate of L.D. 1280, An Act Regarding Generic Drug Pricing.
As senators, we recognize that the cost of prescription drugs poses a real burden for many of our constituents. We also understand that generic drugs frequently promise affordable medicine at a lower price. And we recognize that the sponsors of L.D. 1280 believe, sincerely, that it will provide relief from high drug prices and make more affordable generics more widely available for Mainers.
However, we believe the policy contained within L.D. 1280 will not achieve those desired results. Contrary to popular opinion, generic drugs are not always the most affordable alternative for consumers. In 2016, Attorney General Janet Mills joined 19 other states’ attorneys general and filed suit in federal court targeting Mylan Pharmaceuticals and five other generic manufacturers, alleging anticompetitive business conduct – including price fixing. According to prosecutors, generic drug company collusion has resulted in harmful economic consequences for healthcare consumers.
Mylan’s decision to hike prices on potentially life-saving Epi Pens by more than 500 percent led to strident criticism by Congress. The Inspector General for the federal Department of Health and Human Services is currently asserting Mylan overcharged Medicaid approximately $1.7 billion on the sale of Epi Pens.
Mylan has no footprint and not a single employee in Maine. But they stand to gain tremendously from passage of this bill.
L.D. 1280 would provide expedited access for generic manufacturers to a restricted class of brand name prescription drugs – about 70 out of several thousand medicines – that the FDA has approved for sale only by brand manufacturers who agree to comply with specific safety restrictions on how these drugs are produced, prescribed, administered and sold to consumers.
For this small set of drugs, producers are required to deploy extensive safety protections approved by the Food and Drug Administration to ensure no human is exposed to potentially deadly side effects. These FDA conditions exist to distinguish the potentially life-threatening side effects presented by these drugs and the need to manage the significant risks these medications pose to public health and safety.
However, L.D. 1280 doesn’t speak to safety regulations at all. And it leaves a huge question of liability unanswered: If a generic drug acquired under the auspices of this state law were to make a patient sick, or even cause a death, who would be liable? The generic producer, or the name-brand manufacturer?
L.D. 1280 creates this uncertainty by allowing Mylan and other generic drug manufacturers to legally circumvent the regulatory process established by the FDA to grant approval for the sale of a restricted brand name drug to a generic manufacturer. Mylan contends that the brand name manufacturers of these “restricted” drugs employ federal regulations as “an excuse” to prevent access to the drug by generic manufacturers. Their message is that “Big Pharma” is intent on blocking consumers from enjoying lower retail prices for these specialized prescriptions.
Contrast their claim of “unnecessary delay” to these restricted drugs with consumer data that outlines a generic marketplace where 88 percent of all prescriptions filled at your local pharmacy involve generic equivalents to brand name medications.
Despite Mylan’s claim that restrictions have an adverse effect on their industry, generic pharmaceuticals have enjoyed a market that realized approximately $74 billion in sales in 2015. L.D. 1280 compels Maine’s attorney general to bring a lawsuit against brand name manufacturers to make these restricted drugs available “without delay or restriction,” despite existing FDA safety restrictions and the likelihood that brand companies would face federal sanctions for complying with Maine law.
Should the attorney general not prevail in the courtroom, Maine taxpayers would be liable for the cost of litigation and attorney fees. We would assume the financial risks of legal action while accepting the absence of any statutory language requiring a generic company to use the contested drug for the purpose of developing a generic alternative. Mylan could simply resell the acquired drug to another manufacturer and at any price.
There is no win in this proposal for anyone but Mylan, themselves a large pharmaceutical company. We urge our fellow elected representatives to reject this legislation.
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