Key Healthcare Challenges for Obama, Congress

Jill Wechsler Washington EditorEfforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate. House Republicans will continue to challenge various provisions in the health care legislation, but key provisions for pharmaceutical companies, such as rebates on drugs for seniors in the Part D coverage gap and authorization for biosimilars, are unlikely to change. Read more »

Concerns Raised Over the Comparability of Branded/Generic-Drugs

Stephanie Sutton Pharm Tech EuropeLast week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product. The drug in question, Budeprion XL 300 mg, was approved in the US in December 2006 as a generic form of GlaxoSmithKline’s antidepressent drug, Wellbutrin XL 300 mg. Read more »

Compounding Crisis Spotlights Regulatory Confusion

Jill Wechsler Washington EditorA national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths and 91 ill, with the numbers rising daily. Thousands of individuals have been exposed to some 17,000 vials of methylprednisolone acetate produced by the New England Compounding Center (NECC) and shipped to 23 states in recent months. Read more »

Is FDA putting your company’s confidential data at risk?

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.  Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

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Colored Brain Sparks FDA Warning Letter

Stephanie Sutton Pharm Tech EuropeWarning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them. Not only are warning letters issued by FDA for cGMP deficiencies, letters can also be initiated by marketing or advertising blunders, including the misuse of social media and product websites.

Last week, Eli Lilly received an FDA Warning Letter after the agency’s routine monitoring and surveillance program spotted an image of a colored brain on the website for Amyvid, a diagnostic PET tracer used by healthcare professionals when evaluating Alzheimer’s Disease and other causes of cognitive decline. According to FDA, the brain classifies as misbranding because Amyvid’s product labeling states that images must be displayed and reviewed in black and white. Read more »

FDA Eyes More Foreign Inspections

Stephanie Sutton Pharm Tech EuropeIt’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to. For a start, FDA only has a limited ability to require foreign establishments to allow inspectors into the facilities and logistical problems also mean that inspections cannot be performed unannounced.  In addition, the cost of overseas inspections can be a huge burden and regulators, like the rest of the pharmaceutical industry, are being squeezed by today’s unsettled economic environment. However, I was still surprised this week to learn at how infrequently these inspections are performed. Because of limited resources, FDA can only inspect generic-drug manufacturers outside of the US every 7 to 13 years. Read more »

House is Stingy with Proposed FDA Funding

Amy RitterThe House Appropriations Committee released the fiscal year 2013 Agriculture Appropriations bill, which, sets proposed spending levels for FDA as well as for other programs. The bill calls for nearly $ 2.5 billion in discretionary funding, a cut of $16.3 million, or 0.7%, below last year’s level. Total proposed funding for the FDA, including user fees, is $3.8 billion. Read more »

Putting FDA’s “Process Validation” Guidance into Action

Guest blog by Justin O. Neway, PhD., Vice President & Chief Science Officer, Aegis Analytical, jneway@aegiscorp.com

More than a year has passed since the FDA issued its guidance, “Process Validation: General  Principles and Practices,” which describes process validation in three stages – Process Design, Process Qualification and Continued Process Verification. Companies are making progress with how to incorporate these guidelines cost effectively for science-based decision making that improves quality–the consequences of poor quality are too costly. Read more »

Expanding International GMP Collaboration

Stephanie Sutton Pharm Tech EuropeMedicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now in the area of GMP inspections of API manufacturers, but now the partners are seeking to further expand the international effort by looking to include additional partners. Read more »

Is the US Facing a Pharmaceutical Manufacturing Gap?

Patricia Van Arnum PharmTech editor Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect? Read more »

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