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Pharmaceutical Manufacturer Attorney

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Pharmaceutical Wholesaler Lawyer

Pharmaceutical manufacturers and wholesalers have several complex laws, regulations, and requirements to follow. They often face significant scrutiny from the FDA, DEA, state boards of pharmacy, and accreditation organizations such as NABP.  Specialty medication manufacturers also face challenges due to the e actions of Pharmacy Benefit Managers (PBMs) and the PBMs’ role in increasing drug costs for patients who need them. Protecting your company from licensing issues, product liability claims, and ensuring that those claims are handled well is essential to the health and growth of your wholesaler or manufacturing business. A pharmaceutical manufacturer or wholesaler lawyer can be an invaluable asset to:

  • Protect your business by mitigating liabilities and risk;
  • Defend against PBM actions and state Medicaid rebate inaccuracies;
  • Address the issues in the drug supply chain;
  • Leverage self imposed and FDA mandated Limited Distribution Drug (LDD) supply chain channels; and
  • Find unique solutions for your business and its relationship with pharmacies.

At Boesen & Snow Law, we can guide you through these issues. Our team is made up of professionals with more than 50 years of combined experience, with backgrounds in business, pharmacy management, and other areas of healthcare. We want to help pharmacy drug manufacturers and wholesalers manage a productive and profitable business. We also want to help you do so while complying with state and federal regulations and providing important pharmaceutical supplies to pharmacies.

Our attorneys can help you whether you are currently facing liability, legal problems, or whether you want to prevent these issues before they happen. If you are under review, audit, or need improved policies, the attorneys at Boesen & Snow can help defend you and become long-term business partners. Our firm is located in Arizona, but we help clients nationwide. We have a deep understanding of the laws and requirements in many states and can help you comply with those requirements.

The Risks of Pharmacy Benefit Managers for Manufacturers, Pharmacies, and Wholesalers

Pharmacy Benefits Managers (PBMs) are an unfortunate component of the business operations of many pharmacies. Unfortunately, PBMs can also cause significant monetary and regulatory challenges with pharmacies, manufacturers, wholesalers, insurance providers, and the relationship between these businesses. If your company contracts with PBMs, there are several unique challenges to overcome. Companies that don’t work with PBMs must also deal with the influence PBMs have on the industry as a whole.

PBMs pose significant challenges to   almost every sector of the pharmaceutical industry and pharmacy industry with  impact to the the following:

  • Insurance and copayment programs;
  • Prescription drug prices;
  • Formulary management;
  • Patient access to vital medications;
  • Rebate demands on manufacturers; and
  • Drug reimbursement to pharmacies.

Compliance with Pharmacy Benefit Managers’ Provider Manuals and Contracts

As a pharmacy provider, pharmaceutical manufacturer, or wholesaler business, your operation needs to have policies and procedures  in place to follow PBM contract obligations. When you work with a pharmaceutical manufacturer attorney, they can review your business for gaps in compliance  and clear and present liabilities. PBM audits and other actions can cause financial harm to your business including the ability to even contract at all and have access to the hundreds of millions of patients that have pharmacy benefits managed by these largely unregulated and unlicensed behemoths.. It’s essential that your company understands the tactics and contract obligations enforced by PBMs and know how to work with these businesses that are not your partners. An attorney will be able to help you through this complex issue and keep your business sustainable and protected.

There are several ways the PBMs use their power over pharmacies, manufacturers, and wholesalers, often to the detriment of the business and the public. This includes:

  • Formulary Management: The prescription drug formulary and the drugs that are placed on it are controlled by PBMs. PBMs often require manufacturer rebates to get prescription drugs on that list and may remove drugs already on the formulary. This can lead to complex, confusing, and changing formularies.
  • Manufacturers and Rebate Aggregators: Manufacturers have to negotiate with PBMs and rebate aggregators on drug prices. This often leads to PBMs and aggregators increasing their profit to the detriment of patients, pharmacies, manufacturers, and wholesalers.
  • Copays and Patient Affordability: PBMs often focus on how manufacturers, wholesalers, pharmacies, and healthcare insurance providers give benefits to patients. This includes copay programs, assistance programs, and other systems. These systems are very helpful to patients but can often increase liability for companies.

An attorney can improve compliance while improving negotiation and complex relationships with PBMs.

Drug Supply Chain Federal Regulation

Pharmaceutical manufacturers and wholesalers are an essential part of the drug supply chain. This is governed and regulated by several federal agencies, including but not limited to:

  1. The Food and Drug Administration (FDA). Through the Drug Supply Chain Security Act (DSCSA), the FDA ensures the security of the drug supply chain to provide safe drugs to patients. Drug manufacturers and suppliers have to follow regulations for manufacture, packaging, repackaging, storage, and transportation of pharmaceuticals and be registered and licensed properly.
  2. The Drug Enforcement Administration (DEA). Through the Controlled Substances Act (CSA), the DEA enforces the supply and security of controlled substances to ensure they are accounted for and don’t end up outside of the supply chain. Prescription drugs and other controlled substances have to be monitored during transit and while in storage.
  3. The Environmental Protection Agency (EPA). Through the Resource Conservation and Recovery Act (RCRA), the EPA enforces the safe and correct disposal of hazardous materials. This includes certain pharmaceutical devices and drugs.
  4. State Boards of Pharmacy. These entities license both traditional and virtual drug manufacturers and virtual wholesalers.  Each state has a board of pharmacy, which provides permits to wholesalers, distributors, manufacturers, and others in the pharmaceutical supply chain. It’s essential to properly comply with the state and federal regulations. Violating these laws and guidelines can lead to administrative and civil penalties that can severely harm a business.

A manufacturer or wholesaler attorney can review your systems to determine if the correct procedures are in place.

How the FDA Impacts Drug Manufacturers

The FDA has a significant effect on important parts of a manufacturer or wholesaler company’s work, including:

  • The promotion, marketing, and advertising of prescription drugs and medical devices;
  • Labeling of medical devices and prescription drugs; and
  • Registering and listing of prescription drugs and medical devices.

These are all important aspects of a manufacturer’s business. It’s important to take care of labeling off-label drugs and their promotion and marketing. An attorney can help you evaluate these aspects of manufacturing and wholesaling pharmaceuticals.

When Does HIPAA Apply to Drug Manufacturers and Wholesalers?

Depending on the state a company operates in, the Health Insurance Portability and Accountability Act (HIPAA) may impact the business. Many manufacturers and wholesalers need patient prescription data. However, businesses must be aware of the state laws, the state laws where they are requesting data, and federal laws. HIPAA and similar laws ensure privacy and security for patient information. In many cases, HIPAA creates a barrier that requires careful navigation when pharmaceutical manufacturers and wholesalers require access to certain pieces of information protected by state and federal privacy laws.. These industries can still violate state and federal laws such as HIPAA if they misuse patient information.

Violations of these laws can lead to severe civil penalties. It’s important to review policy and training procedures to ensure that your company is respecting the necessary privacy laws. An attorney can help you review and improve this system.

How Does an Attorney Help Pharmaceutical Manufacturers and Wholesalers?

Whether you are beginning a company in the pharmaceutical supply chain or have been working for years, compliance law needs attention. Pharmaceutical companies are some of the most highly regulated businesses, subject to state and federal laws for businesses, employment, healthcare, controlled substances, and more. It’s not often easy to comply with these laws. However, it is essential for public safety and for the health of your company. The sooner you begin working with an experienced attorney, the more effectively you can protect yourself against future liabilities. An attorney with Boesen & Snow can help you create policies or determine the weaknesses in your current training system.

If you are facing an audit, investigation, or other transparency requirements from governmental agencies, our attorneys can be on your side. We can help you comply with these investigations while protecting your interests and fighting for the most ideal outcome.

We can help you evaluate your current standard operating procedures (SOPs) and policies for liabilities.  If you are already the recipient of a complaint or adverse observation, Boesen & Snow’s attorneys can help you defend your company. Our team has experience with several laws that affect manufacturers and wholesalers, including:

  • State regulation, including controlled substance regulation
  • Corporate compliance
  • Federal regulations, including DEA, FDA, and EPA laws
  • HIPAA and Health Information Technology for Economic and Clinical Health Act (HITECH)
  • Anti-Kickback laws
  • Stark Law
  • False Claims Act
  • Insurance, Medicaid, and Medicare rules and regulations
  • Federal Trade Commission (FTC) rules

Creating a compliance system for your manufacturing or wholesale company includes employee training, safety procedures, and effective checks of the third parties you work with. At Boesen & Snow, we have dealt with these and other pharmaceutical compliance issues for many years. Our team is uniquely qualified to help your business follow essential laws and regulations while improving stability and profit.

Boesen & Snow, LLC: Limiting Manufacturer and Wholesaler Liability

At Boesen & Snow, we understand what you’re dealing with because we have experienced the same situations. Not only have we worked in the industry, but we have years of working with business leaders and professionals like you. We understand the complexities of healthcare and pharmacy law and can use our experience to represent you. Whether you are facing investigation, audits or want to review your system for liability, our team can help. We want to bring you exceptional legal care and protect your business against liability. Contact the team at Boesen & Snow today and see how we can improve the future of your pharmaceutical company.

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