Drug Price Discussion Continues
Hurricane Maria impacts drug supply
Health care experts are worried that damage inflicted on Puerto Rico by Hurricane Maria could lead to drug shortages. Puerto Rico pharmaceutical plants manufacture one quarter of U.S. pharmaceutical exports, and the industry comprises nearly three quarters of Puerto Rico’s exports. Most of the island is without power and communication has been hampered by destroyed cell phone towers. Puerto Ricans are also facing a shortage of essential supplies, including food, medicine and construction materials needed for rebuilding. Some analysts believe recovery could cost as much as $95 billion.
Drug companies pulled down more than $98 billion from just 20 drugs in 2016
Drugmakers reaped more than $98 billion in gross U.S. sales last year from the 20 top-selling drugs alone, according to data from the pharmaceutical research firm QuintilesIMS. The staggering sum—which is $20 billion more than the U.S. Treasury department’s budget—reflect the effects of drug price increases that have far outpaced inflation. The gross sales numbers do not account for discounts and rebates provided by drug manufacturers, which isestimatesdat about 25 percent.
AbbVie may not honor promise to limit price increases
Executives at AbbVie may back away from their pledge to not increase prices by more than 10 percent or once in a year. According to investor notes, AbbVie executives originally made the pledge because they were concerned a tumultuous political landscape could lead to laws or regulations aimed at curbing high drug costs, but AbbVie no longer believes such a shift will come.
NGA will hold strategy session on hepatitis C drugs
The National Governor’s Association (NGA) will meet to develop strategies for combatting high drug costs, particularly for specialty drugs treating hepatitis C. Breakthrough treatments for the condition have had a high cure rate, but high prices have left state Medicaid programs struggling to cover the treatment.
Senators call for inquiry into Allergan’s patent deal with St. Regis Mohawk Tribe
Four Senators are asking the Senate Judiciary Committee to investigate Allergan’s sale of a half-dozen patents to the St Regis Mohawk Tribe. Sens. Richard Blumenthal (D-CT), Sherrod Brown (D-OH), Bob Casey (D-PA) and Maggie Hassan (D-NH) are decrying the sale as a transparent attempt to prevent competition and maintain high drug prices. Under the deal, Allergan transferred the patent rights to the tribe, who then provided Allergan with an exclusive license to market the product in exchange for $13.75 million initially and $15 million in annual royalties. Because the tribe has sovereignty in the United States, it is exempt from certain legal challenges, including those used by generic drugmakers to challenge brand name patents.
Massachusetts looks to lower drug spending in Medicaid
Massachusetts aims to curb Medicaid drug spending through a waiver that, if accepted, would allow the state to exclude some drugs from coverage. Medicaid programs are required to cover almost all drugs approved by the FDA, regardless of price. The waiver would let the state create a list of drugs that are not considered clinically effective to be excluded from coverage. Some doctors have voiced concerned over how the coverage changes could impact patients.
Safety program settlements could signal increase in FDA action
Aegerion Pharmaceuticals will pay $40 million in a settlement regarding the illegal marketing of its cholesterol medicine in violation of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) safety program. The company was accused of marketing Juxtapid, which costs up to $300,000 a year and was approved to treat a rare form of high cholesterol, to a broader pool of patients to increase sales. This is the second of two recent cases related to the REMS. The two settlements could signal that the FDA is honing in on violations of the safety program and is willing to take action.
FDA side-effect database improvements will allow easier searches
The FDA has made improvements to its online database of side effect reports of drugs to allow users to easily search by product, age, side effect or the year of a reaction. Previously, database users had to have coding knowledge to search the database and were forced to file Freedom of Information Act requests if they wanted the full report. The FDA hopes the move will encourage more patients and doctors to submit more detailed side effect reports and raise awareness that the database is available for consumers.
FDA works with software companies on precertification program
The FDA is working with nine medical software developers to create a precertification program that would shift the agency’s efforts from evaluating individual products to evaluating producers. Under the program, software companies that have been preapproved by the FDA would be allowed to sell low-risk software for medical devices without having to gain approval for each piece of software. Additional, higher-risk software developed by precertified organizations would undergo a streamlined approval process.
The Opioid Epidemic
FDA targets illegal, online opioid retailers
The FDA targeted more than 500 websites said to be illegally selling unapproved versions of prescription drugs, including opioids. The agency sent 13 letters to website operators and seized about 100 domain names. The action is part of a larger effort slow the flow of illegal drugs through international mail facilities located in the United States.
Insurance policy can help combat opioid addiction
Some Americans who take prescription opioids receive their prescriptions from as many as 20 different physicians. “Doctor shopping” is possible because providers are unaware of the multiple prescriptions. To combat the problem, state Medicaid programs are starting reimbursement lock-in policies. If an enrollee’s billing statements point to doctor shopping, prescriptions for opioids will only be covered if they are written by a single provider of the patient’s choosing. Reducing prescriptions not only lowers costs for the payer and but also helps prevent overdose and the risk of addiction in patients.
Makers of fast-acting opioids will have to pay for training
Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the U.S. Food and Drug Administration (FDA) said on Thursday. The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses for doctors, nurses and pharmacists, FDA Commissioner Scott Gottlieb said in a statement.
Governor of Florida calls for three-day limit on opioid prescriptions
Governor Rick Scott (R-FL) will propose legislation that imposes three-day limits on prescribed opioids and adds $50 million to Florida’s state budget next year to combat the opioid epidemic. If the legislation is enacted, patients would only be able to secure three-day prescriptions unless they meet strict conditions, in which case they can secure a seven-day prescription. The legislation would also require all providers who prescribe or distribute medication to participate in the Florida Prescription Drug Monitoring Program, a statewide database that allows providers and prescribers to monitor prescriptions.