Compliance Resources to Help you Stay Current

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

This article gives a brief overview of the proposed rule and its requirements.
 

Yes – as shown by the Department of Health and Human Services’ (HHS) overruling of the FDA’s approval of the sale of Plan B contraceptive pill to adolescents without a prescription.

This, however, is the first time in history that a senior US government official overruled the FDA’s approval for a drug. Until this, the FDA’s approval for a drug was considered final. The decision by Kathleen Sibelius, the Secretary of the HHS, has set a historical, and controversial, precedent. Many observers (from the industry, scientific and healthcare fields) feel that this has diminished the FDA’s scientific drug approval process. Critics of the decision say that political considerations have trumped scientific decision-making.
 

No. The FDA's Abbreviated New Drug Application or ANDA process, used by generic manufacturers to apply for approval for their copies of drugs, does not require the company to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

Instead, generic manufacturers need to show that their product is bioequivalent or performs in the same manner as the original, innovator drug.

Bioequivalence can be demonstrated by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.

In late November 2011, Ranbaxy won approval from the FDA to start selling its generic version of Pfizer’s cholesterol drug, Lipitor. The approval was given as Pfizer’s patent for the drug had expired.

This article explains how the FDA approves generic drugs and how Pfizer is trying to lessen the impact of the Lipitor patent expiry.

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This article gives a brief overview and summary of the recommendations contained in the guidance.
 

The FDA will soon be implementing a new import screening tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT. This system is expected to improve the current electronic screening system by targeting higher risk products and minimizing delays in shipping lower risk products.

This article gives a brief overview of the PREDICT tool and recent developments in its implementation.

Following good laboratory practices (GLPs) is necessary to ensure that quality is maintained and results are accurate. In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, gives practical tips on the following GLP areas:

• General Laboratory Practices and Test Procedures
• Laboratory Documentation
• Laboratory Training and Personnel Certification

In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, discusses the best ways to conduct cleaning test method validation. Marcelle discusses the various steps involved and different regulatory recommendations for this essential process in the manufacture of drug products.

This article establishes a rationale to justify the level and extension of Environmental Monitoring to be applied at non-sterile pharma facilities based on the risk compound by  factors such as location and product susceptibility to microbial contamination.

The author, Marcelle Cortezia, has ten years of experience with major pharmaceutical companies and is at present a Quality Manager with Dentsply.

The manufacture of pharmaceuticals requires strict adherence to standards and regulations. ISO 14644-1 details the requirements that pharma manufacturers have to follow with respect to clean room environments.

In this article, Yara Almouti, an expert on cGMP in the pharma industry, explains these requirements.

Google has agreed to pay $500 million dollars as a settlement in a Department of Justice inquiry into whether the search engine’s advertisements for online Canadian pharmacies led to illegal imports of prescription drugs.

This article gives details of the allegations against Google and the regulatory violations that led to the inquiry.

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This article describes the background to ePedigrees, current regulations governing their use and implementation status.

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

This article describes the background to the act, summary of its provisions and recent amendments.

The European General Product Safety Directive (2001/95/EC) directive covers nearly all products sold in the European Union. It places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product.

Warning letter sent to Jilin Shulan Synthetic Pharmaceutical Co. regarding significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs.

The US Food and Drug Administration (FDA) regulates all vaccines to ensure safety and effectiveness. No federal laws mandating vaccination exist, but all 50 states require certain vaccinations (exemptions allowed) for children entering public schools.

Vaccines have contributed to a significant reduction in many childhood diseases, such as diphtheria, measles, and whooping cough. Other diseases, such as polio and smallpox, have been eliminated in the United States due to effective vaccines.

The Vaccines for Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. The Centers for Disease Control and Prevention (CDC) has a pediatric immunization schedule.

Program for Distribution of Pediatric Vaccines

 Recommended Immunization Schedule for Persons Aged 0 through 18 Months

Approved by the American Academy of Pediatrics, the Advisory Committee on Immunizations Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians

The pediatric vaccination schedule is progressively more complex to implement and demands a well-designed infrastructure. The first 2 years of life is when approximately 80% of immunizations recommended for children are scheduled.

 Collaborating agencies

·         Centers for Disease Control and Prevention

·         Centers for Medicare & Medicaid Services (CMS)

·         State Medicaid agencies

·         Health Resources and Services Administration (HRSA)

·         Indian Health Services (IHS)

·         National, state, and local organizations representing the private healthcare sector

 Five main functions for the development of immunization registry systems as per pediatric standards

·         To monitor the immunization status of individuals

·         To monitor the immunization status of defined populations

·         To remind individuals or parents of the need for immunization

·         To recall individuals in need of immunization

·         To remind practitioners to administer needed immunizations when they see patients who are due or overdue for vaccination

Steps to take when vaccinating a child

Source

http://www.pediatric.theclinics.com/article/S0031-3955(05)70215-7/abstract

http://cpj.sagepub.com/content/42/7/603.abstract

http://www.nursingcenter.com/library/JournalArticle.asp?Article_ID=848490

http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf

http://aapredbook.aappublications.org/resources/IZSchedule0-6yrs.pdf

http://vaccines.procon.org/

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048750.htm

For the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison it is important to maintain strict cleanroom cleanliness and sterility in their Class 7 and 8 cleanrooms. If contaminated with microorganisms, the products the WCBF manufactures can adversely harm patients. In addition, the steep price of product rejects and recalls makes it crucial to ensure high product yields.

Defined by the FDA, the Process Analytical Technology or PAT is “a system for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality". PAT can better be understood as an initiative to enhance quality of products and manufacturing process and as an unremitting process of improvement.

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.