Rock-Bottom Drug Prices For Older Generic Drugs Contribute To Worsening Shortages, FDA Says

The New York Times: U.S. Blames Drug Shortages On Low Prices And A ‘Broken Marketplace’
Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published on Tuesday. The report, the work of a task force led by the Food and Drug Administration and comprising representatives from various federal agencies, recommended that buyers like hospitals consider paying higher prices for older generic drugs. (Rabin, 10/29)

Stat: FDA Issues New Recommendations To Combat Drug Shortages, But Can It Really Fix The Problem?
In a new report, the Food and Drug Administration noted that the number of ongoing shortages has been steadily rising — reaching about 110 — after peaking in 2011 and then declining until last year. Moreover, the agency analyzed 163 drugs for which shortages existed and found that most were relatively lower priced and financially unattractive for manufacturers. (Silverman, 10/29)

Reuters: Ex-FDA Chief Gottlieb Sees Investment Opportunity In 'Unloved' Antibiotics
As a private investor, former U.S. Food and Drug Administration Commissioner Scott Gottlieb is focused on an area where few have found success in recent years: developing new antibiotics. Since leaving the FDA in April, Gottlieb has revealed little about what types of investments he would make in his new role at New Enterprise Associates, one of the country's largest venture capital firms where he worked prior to his time in government. (Spalding, 10/29)

The Hill: House Democrats Clash Over Pelosi's Drug Pricing Bill
Moderate and progressive House Democrats are clashing with each other over changes to Speaker Nancy Pelosi’s (D-Calif.) signature plan to lower drug prices. A group of centrists, including Rep. Stephanie Murphy (D-Fla.), co-chairwoman of the moderate Blue Dog Coalition, has warned leadership that some moderate Democrats might vote against the bill if it moves any further to the left, sources say. (Sullivan, 10/30)

The Associated Press: Pfizer Narrows Its Focus And Profit Soars In 3Q
Pfizer's third-quarter profit nearly doubled after it booked an $8.1 billion gain on paper by creating a consumer health products joint venture, a key part of the drugmaker's plan to slim down and focus on innovative medicines. Those include blockbusters like blood thinner Eliquis, breast cancer drug Ibrance and rheumatoid arthritis pill Xeljanz, which all saw sales jump 18% or more in the latest quarter. (10/29)

Stat: After Big Gains, Cystic Fibrosis Foundation Bankrolls Research Toward Cures — And Drugs For Those Left Out
Last week, the cystic fibrosis community celebrated the approval of a new drug from Vertex (VRTX) Pharmaceuticals, a decision that offers the large majority of patients access to cutting-edge treatments. Those treatments, however, don’t cover patients with certain rare mutations. And they are not cures for anyone. (Joseph, 10/30)

NH Times Union: NH Lawmakers Seek Insulin Price Cap 
The head of an advocacy group for people with Type 1 diabetes called a “great first step,” a proposed cap on how much health insurers can charge a month for patients to get insulin. State Rep. Garrett Muscatel, D-Hanover, and Senate Majority Leader Dan Feltes, D-Concord, announced Tuesday they were filing this bill for the 2020 session that would set a price ceiling patients would have to pay of $100 for a 30-day supply. (Landrigan, 10/29)

Stat: Former Axovant CEO David Hung Is Back — Leading A Cancer Biotech With Hefty Funding
The company, Nuvation Bio, aims to be ambitious — according to the press release announcing the round, it has seven “mechanistically distinct programs.” It did not disclose any details about what those programs are, however. Nuvation’s CEO is Dr. David Hung. For Hung, his leadership of the company marks a return to oncology and to the CEO seat. Hung is best known for founding Medivation — which developed Xtandi, a drug for prostate cancer — and then selling the company to Pfizer (PFE) for $14 billion in 2016. (Sheridan, 10/28)

Reuters: New Tuberculosis Treatment For Developing Countries To Cost $1,040
A newly approved three-drug treatment for tuberculosis will be available in 150 countries including India and South Africa, priced at $1,040 for a complete regimen, more than twice the cost proposed in the past by advocacy groups for other treatments. The United Nations-backed Stop TB Partnership said on Monday that BPaL would be obtainable in eligible countries through the Global Drug Facility (GDF), a global provider of TB medicines created in 2001 to negotiate lower prices for treatments. (Maddipatla and Mishra, 10/28)

Bloomberg Law: Oklahoma Drug Pricing Law Latest To Face Legal Challenge
Oklahoma is the latest state to face an ERISA challenge to a law regulating pharmacy benefit managers, according to a complaint filed in the Western District of Oklahoma by the Pharmaceutical Care Management Association. Oklahoma’s Patient’s Right to Pharmacy Choice Act, which is aimed at curbing controversial practices by PBMs like Express Scripts and CVS Health, is preempted by the federal Employee Retirement Income Security Act and Medicare Part D regulations, the PCMA argued in an Oct. 25 lawsuit. (Wille, 10/28)

Bloomberg Law: Illinois Ends Protracted Drug Pricing Case With $248 Million Deal
Fifteen drugmakers will pay $248 million to settle allegations they manipulated wholesale prices to increase their Medicaid reimbursements, Illinois Attorney General Kwame Raoul (D) said Oct. 28. The settlement brings to $678 million the amount Illinois has been able to recover through a 2005 lawsuit against more than four dozen drug companies. This settlement, announced Oct. 28, resolves the litigation, a statement from Raoul’s office said. (Brown, 10/28)

The Wall Street Journal: Vertex Resolves Yearslong Drug-Price Dispute In England
Vertex Pharmaceuticals Inc. has secured a deal to supply its cystic fibrosis treatments to England’s National Health Service, breaking a four-year deadlock over drug prices that effectively shut the company out of one of its biggest potential markets. Cystic fibrosis causes breathing difficulties. It is an inherited disease and nearly one in ten sufferers globally lives in England—a genetic anomaly that makes the nation unusually important for the Boston-based drug company. (Roland, 10/24)

Stat: More New Medicines Had Publicly Supported Research Than You Might Think
As debate grows over the role that taxpayer dollars play in drug discovery, an analysis finds one in four new medicines approved by regulators over the past decade benefited from publicly supported late-stage research or spinoff companies that were created by public sector research institutions. Moreover, drugs that were approved following major public financing were more likely to have won speedier approvals by the Food and Drug Administration. (Silverman, 10/23)