- FDA Approving Drugs at Breakneck Speed, Raising Alarm (msn.com)
The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates...“It isn’t that we changed our policies and are saying we are going to approve drugs faster,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research...“The difference now is we are going to see more of those because of the science. If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.”...READ MORE
- Lawmakers up pressure on Novartis in wake of data manipulation (biopharmadive.com)
Sen. Chuck Grassley...is demanding a full accounting from Novartis of its investigation into faulty data it submitted to the Food and Drug Administration in seeking approval for the gene therapy Zolgensma...Grassley seeks records from Novartis related to its internal inquiry into the data manipulation, as well as any tied to its decision to delay informing the FDA until after the agency had approved Zolgensma..."Such conduct is reprehensible and could have an adverse effect on patients,"...READ MORE
- Pharmacy takes FDA to task in citizen petition over tainted valsartan (fiercepharma.com)
The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps to limit their use...In a citizen petition...Valisure says the FDA has established acceptable limits for impurities such as those commonly known as NDMA and NDEA after they were discovered in heart drugs last year, leading to massive global recalls...But it claims the FDA has not lowered the acceptable level for the solvent DMF, although it “has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible” for the appearance of the impurities in the U.S. drug supply...The petition says the FDA needs to investigate the use of the solvent N,N-Dimethylformamide in drug manufacturing since it is classified as a Class 2 carcinogen...READ MORE
- Canada to create national drug agency to help cut cost of medicines (reuters.com)
Canada will create a national drug agency to help cut the cost of prescription medications as part of a plan to broaden the state-funded healthcare program, the finance ministry said in its budget...Unlike other countries with universal healthcare, Canada does not cover prescription drugs, leaving most Canadians to rely on a mixture of public and private insurance plans...Prescription drug spending in Canada has jumped to C$33.7 billion ($25.3 billion) in 2018 from C$2.6 billion in 1985 and a promise to boost drug coverage is set to be a major plank for the ruling Liberals in an election this October...The new Canada Drug Agency would “take a coordinated approach to assessing effectiveness and negotiating prescription drug prices,” which could help lower the cost of medications by up to C$3 billion a year in the long term...READ MORE
- Drugs@FDA: FDA Approved Drug Products – November 14, 2019 (accessdata.fda.gov)
- Putting safety first: Retailers wrestle with supply chain safety amid drug import push (drugstorenews.com)
Product safety is a multifaceted issue for any retailer dealing with the pharmacy and prescriptions, and the systems that are in place to protect the quality and integrity of the goods offered constantly are evolving to strengthen the industry’s defenses...One of the key loopholes between consumers and the dangers of unsafe products, however, is the potential for the introduction of items from other countries that fail to meet the rigorous safety standards of the United States...The Food Safety Modernization Act, which took effect in 2011, sought to close that gap by imposing tighter regulation around the import of foods and ingredients from overseas...Market pressures in the pharmaceutical industry, however, have led officials at both the state and federal levels to explore the possibility of bringing drugs in from other countries at a lower cost, potentially circumventing the Food and Drug Administration’s close oversight of U.S.-made medications...the...National Association of Chain Drug Stores see several potential problems with the import of prescription medications from other countries, including:
Issues around the adequacy, consistency and integrity of the supply;
Issues around quality and safety;
Problems with maintaining dual inventories inside pharmacies;
Burdensome testing requirements;
Costs of establishing an infrastructure for imported drugs; and
Liabilities for injuries caused by imported drugs...READ MORE
- FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials (biopharmadive.com)
Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research
Woodcock is director of the FDA's Center for Drug Evaluation and Research. She sat down with BioPharma Dive...for a wide-ranging interview that touched on accelerated approvals, emerging clinical trial designs and her long-term concerns for the agency...
- Renewed debate over accelerated approval
- An adaptive future for clinical trials
- Optimism on continuous manufacturing
- Drugs@FDA: FDA Approved Drug Products – September 20, 2019 (accessdata.fda.gov)
Recent New and Generic Drug Approvals
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
- New drug to boost women’s sex drive approved in US (apnews.com)AMAG wins FDA nod for Vyleesi. Could it be the ‘female Viagra’ that Addyi never was? (fiercepharma.com)
U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours...The medication OK’d...by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men...The upside of the new drug “is that you only use it when you need it,”...“The downside is that it’s a shot — and some people are very squeamish.”...The FDA approved the new drug, Vyleesi (pronounced vie-LEE’-see), for premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. The most common side effect in company studies was nausea...READ MORE
- Exclusive: Novartis pitches discounts on pricey gene therapy for deadly muscle disorder (reuters.com)
Novartis AG is offering price discounts in negotiations with U.S. health insurers on its gene therapy for spinal muscular atrophy, a treatment that could cost more than a million dollars, but the gesture comes with strings attached...The Swiss drugmaker wants insurers to commit to coverage for patients identified with the rare and often deadly disease...Novartis also seeks their support for widespread screening to identify newborns with SMA, and to ensure quick authorization for the gene therapy, with the aim of starting treatment within two weeks of diagnosis...The U.S. Food and Drug Administration is due to decide this month on approval for Novartis’ Zolgensma. Novartis, which has made a huge bet on gene therapy for future growth, says the one-time treatment could be a cure for SMA and is pushing for a price in the range of $1.5 million to $5 million. That would make Zolgensma the most expensive new therapy to date...READ MORE