- Many ‘me-too’ drugs didn’t start off that way: report (pharmalot.com)Nearly All Later Entrants to Drug Classes Were in Clinical Testing or Regulatory Review Before First-in-Class Approval (csdd.tufts.edu)
For many years, drug makers were criticized for racing to market with so-called me-too medicines. These are drugs that arrive in the marketplace after the first in a particular class of medicines is approved for treating a certain malady…Instead of developing something that offers little, if any, improvement over a first-in-class drug…critics have contended that drug makers should use precious R&D resources to focus on developing therapies for ailments that are lacking treatments…Now...a new analysis suggests the me-too phenomenon often occurred because companies were simply engaging in concurrent drug development, rather than opportunistic efforts to ride on the coattails of a successful medicine.
- Pharmacy Track-and-Trace Compliance Deadline Again Delayed by FDA (pharmacytimes.com)Are you ready for the Drug Supply Chain Security Act? (fda.gov)
FDA has once again delayed its enforcement of product tracing requirements for pharmacies under the Drug Supply Chain Security Act...Although these track-and-trace requirements took effect on July 1, 2015, the FDA said it would not enforce the product tracing obligations for pharmacies until November 1, 2015, which it has now extended to March (March 1,2016)…FDA granted this latest extension because “some dispensers—primarily smaller, independent pharmacies and health systems—have expressed that they need additional time,” …In the meantime, pharmacies that do not capture and maintain product tracing information, or accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized…this compliance policy does not extend to other requirements for dispensers under the DSCSA, which include verification related to suspect and illegitimate product (including quarantine, investigation, notification, and record keeping) and engaging in transactions only with authorized trading partners.
- Pacira sues for free speech; FDA pulls off-label warning letter. What gives? (fiercepharmamarketing.com)
On second thought, Pacira Pharmaceuticals, the FDA might just take it back...the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices…the FDA warning letter--now taken down from the agency website--Pacira had claimed that Exparel (bupivacaine), its pain drug and lead product, could work for up to three days at a time, though it's only approved for 24-hour pain relief… It would seem like a good old-fashioned pharma-government tussle over what companies can and cannot say about their products. But the argument has changed significantly, thanks to a series of court rulings that could open the door for drugmakers to market their products in previously unacceptable--even previously illegal--ways...
- Sex enhancement product ingredients can be risky (reviewjournal.com)Lamar Odom released from Sunrise, friend confirms (reviewjournal.com)Lamar Odom speaks to doctors, gives thumbs-up (reviewjournal.com)Sheriff: Lamar Odom used cocaine, sexual performance enhancers before being found unconscious (reviewjournal.com)
Products marketed to enhance sexual performance, such as the one used by Lamar Odom at a Pahrump brothel, might contain other ingredients that can pose risks to users, especially when used in combination with other drugs…more information is needed before any determination can be made about the cause of Odom's health complications…The former NBA basketball star was hospitalized...after being found unconscious at the brothel…Unapproved remedies for erectile dysfunction may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations…"I could take two herbal supplements off the shelf, and they could claim to be the same thing, and they won't be anything alike," said Jason Penrod, a member of the Nevada State Board of Pharmacy. "The only way you can know for sure is to take your 'herbal Viagra'...and analyze it in a biochemistry lab."…"They may or may not be effective," Dr. Michael Verni of the Urology Center of Las Vegas said. "All the vitamin makers have to prove is that their products are not harmful. They don't have to prove they work."
- FTC raises anticompetitive concerns about FDA naming proposal for biosimilars (pharmalot.com)Nonproprietary Naming of Biological Products Guidance for Industry DRAFT GUIDANCE (fda.gov)In Response to a Request for Comments on Its Guidance for Industry on the “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability” (ftc.gov)
What’s in a name?..A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits…At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine…
- Specialty Pharmaceuticals for Hyperlipidemia — Impact on Insurance Premiums (nejm.org)
Food and Drug Administration recently approved…PCSK9 inhibitors…These novel biologic agents offer the promise of reductions in blood cholesterol levels. This broad indication sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models…At its core, the current pricing model for these products is driven by a transformation in the pharmaceutical industry, whereby 84% of prescriptions are filled with generic products and follow-on biologics have the potential to disrupt many established markets and firms…for most firms, future revenue expectations hinge on novel therapies…without the potential for outsized returns, capital might not be available for early innovation in biotechnology. Pricing pressure on innovative products would drive a fundamental restructuring of the industry and further increase the financial challenges of bringing scientific innovations to the market. It is important that we manage these downside risks carefully as we work toward a more sustainable pricing model in this market.
- The US FDA has issued an alert warning the public not to take drugs marked as sterile by compounding firm Qualgen. (outsourcing-pharma.com)FDA alerts health care professionals not to use sterile drug products from Qualgen (fda.gov)
During an inspection of Qualgen’s facility in Edmond, Oklahoma, FDA investigators observed "insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced," said the agency…The FDA recommended the company cease sterile operations until it fixed the problems, but Qualgen agreed only to voluntarily recall 67 lots of drugs. The recalled products were compounded before September 1, 2015 and have not yet expired…The Food and Drug Administration said it is not aware of any adverse events associated with Qualgen’s products…
- Why the FDA Is Worried About Chinese Drugs in Your Medicine Cabinet (bloomberg.com)
U.S. Food and Drug Administration inspectors at Zhejiang Hisun Pharmaceutical Co….according to agency documents describing problems at the company...There was evidence that quality control staff deleted records of tests that might show a drug was impure. Audit trails disappeared. A paper shredder was kept close by machines that recorded quality data…U.S. and the rest of the world are more dependent than ever on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world…the FDA has made inspections there a priority to keep patients safe. It’s found plenty -- the agency has barred 38 plants in China from exporting some or all of their products to the U.S. for manufacturing violations. And 34 facilities are banned from exporting a blood thinning ingredient, after a past scandal, according to the FDA’s import alert list.
- Drug Firms Buy Pricey Vouchers to Speed Products to Market (wsj.com)
There is a new price surge in the pharmaceutical industry—for a limited number of government-issued vouchers that drug makers… are buying to speed products to market…vouchers require the FDA to shorten its decision deadline to six months… Because companies can also sell the vouchers, a lucrative secondary market has emerged. AbbVie agreed in August to pay $350 million for a voucher from United Therapeutics Corp. ,which received it for developing a pediatric cancer treatment…the voucher program is attracting…criticism…These programs allow sponsors to ‘purchase’ a priority review at the expense of other important public health work in FDA’s portfolio… such as reviewing applications for drugs that treat more serious conditions...Adding to the escalating prices: the vouchers have a scarcity value because only seven have been issued…
- Pharma’s newest nemesis? Nestlé works at the intersection of food and drugs to attack illnesses (fiercepharma.com)
Swiss food company talks turkey with the FDA even as it researches conditions like Alzheimer's…If Big Pharma didn't already have enough to worry about, with patent cliffs, drug price investigations and reluctant payers, it now will have to face the onslaught of a large, well-funded company trying to create hybrid pharma and food products company that would treat conditions from stomach disorders to Alzheimer's disease…the four-year-old health-focused unit of Swiss food giant Nestlé is acting very much like a Big Pharma player these days. It is doing deals for pipeline projects, talking to the FDA about approvals on health-proven products and eyeing the same emerging markets that Big Pharma players have looked to improve their margins…