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PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation. As part of my research for the March feature, I would like to know your answer to the following question.
How has the FDA process validation guidance, Guidance for Industry: Process Validation: General Principles and Practices, changed validation in pharmaceutical manufacturing?
Please send your answers to firstname.lastname@example.org or post them directly here in the comments section.
The second half of 2012 has not been kind to FDA. Last month, Secretary Hamburg was grilled by the House of Representatives for failing to follow-up on warning letters to the New England Compounding Center (NECC), now comes word that a U.S. District Court has ruled that a sales representative’s off-label promotion of a drug was protected speech. The Food, Drug and Cosmetic Act (FDCA) appears to be coming apart at the seams.
In US v. Caronia, the Court ruled that Alfred Caronia, a sales rep promoting Xyrem for Orphan Medical (now Jazz Pharmaceuticals), could make statements about off-label uses of the drug, even though FDCA specifically prohibits “introducing a misbranded drug into interstate commerce.” The Court did not consider whether the statements were true.
Given the Supreme Court’s general affection for sales rep’s free speech rights, it is not out of the question to presume a difficult fight ahead for FDA. While it is too early to suggest that a wholesale rewrite of the FDCA is in order, clearly some significant revisions are in order.
“FDA and industry will need to come to an understanding on what exactly is needed to substantiate a product claim,” notes Pharm Exec Senior Editor Ben Comer.
It’s not just about free speech and drug marketing, though. With more than five hundred patients stricken and 36 deaths from tainted compounded steroid injections, there is an obvious need to clarify FDA authority over compounding pharmacies as well. Given the range of issues surrounding FDA authority a rethinking of the FDCA might just be in order.
Student Innovation Across the Pharma Sciences
Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices Act when it promoted and sold its pain reliever Vioxx. Merck removed Vioxx from shelves in 2004 due to evidence that it increased the risk of heart attacks. According to the Justice Department, Merck began marketing Vioxx as a treatment for rheumatoid arthritis shortly after being approved by FDA as a painkiller in May 1999. However, FDA had not approved it for the treatment of rheumatoid arthritis until 2002. The settlement is reportedly for $220 million and Merck agreed to pay validated claims as well as approved attorneys’ fees, and settlement notice costs.
Merck’s press release on the settlement didn’t mention any admission of wrongdoing. In a company press release, Bruce N. Kuhlik, Merck’s executive vice-president and general counsel, said “This agreement is in the best interest of the company and its shareholders. It reduces the uncertainty of litigation and ongoing defense costs, and helps us to remain focused on bringing forward innovative products and services for our customers.” This is one of several recent examples of off-label drug promotion. Are the millions pharma companies end up paying in lawsuit payouts worth sidestepping FDA rules?
FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.
The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy. But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.
“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.
For back story, see the video on PharmTech.com/PharmTechTV regarding the compounding center and its connection to the recent fungal meningitis outbreak.
The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.
Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US. It seems that, despite the efforts of regulators, industry, and medical professionals, patients continue to misunderstand dosage instructions. Read more »
Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »