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Drug pricing conversation continues
Gottlieb plans to use FDA to challenge high drug prices
FDA Commissioner Gottlieb is planning a multifaceted effort to restrain high prescription-drug prices, centered on speeding cheaper generic medicines onto the U.S. market. Gottlieb says the FDA may intervene in cases where manufacturers use safety or regulatory rules as an excuse for not creating generics. Gottlieb also hopes to streamline the generic approval process and publish lists of old medicines without generic competitors to help lure competition into the market.
Ruling on patent suits could benefit generic drugmakers
The Supreme Court has ruled that patent lawsuits must be filed in the state where a defendant is incorporated or performs regular business. The ruling could be a boon for generic drug companies. Brand drugmakers will now have to file patent infringement cases in different courts; as a result, brand drugmakers will have to spend more to bring cases across the country.
New York law put pressure on drugmakers to curb Medicaid price increases
New York has passed a law designed to curb drug cost increases. If drug prices for New York’s Medicaid program rise more than five percent, New York regulators will have the power to review profit margins and the relative effectiveness of drugs made by manufacturers who do not offer rebates.
FDA head rolls out plan to fight
FDA commissioner Scott Gottlieb has instructed the agency to explore additional ways to fight the opioid epidemic. Potential strategies include training and educating providers on opioid prescription practices and reevaluating if the agency is properly weighing addiction risk when approving drugs. Gottlieb has also recommended curbing the length of prescriptions, a suggestion that has been met with skepticism by addiction experts.
Trump’s Budget Reduces Funding for Addiction Treatment
Trump’s budget proposal, released this week, would reduce funding for addiction treatment, research and prevention. The most damaging proposed cut, critics say, is the president’s 10-year plan to shrink spending for Medicaid, which provides coverage to an estimated three in 10 adults with opioid addiction. Members of Congress have said they are unlikely to approve the budget as written.
FDA and drug approval
McConnell expects Senate to pass FDA user fee bill
Majority Leader Mitch McConnell (R-KY) predicts the Senate will pass legislation authorizing funding for the FDA with bipartisan support. The bill will allow the FDA to continue collecting fees from drugmakers and medical device companies to help cover the cost of assessing new products.
Drug approvals pick up after a slow 2016
The FDA has already approved 21 new prescription drugs in 2017, compared to 9 drugs at this point in 2016. Biopharmaceutical companies have shifted the focus from mass-market medications to specialized and higher-priced drugs, which can be approved on an accelerated review timeline.