Distributors and Emerging Therapies Lawyer
Distributors play a crucial role in the process of bringing emerging therapies to market. However, being on the cutting edge of medical therapies and technologies also means that there are a host of legal issues that must be addressed in all phases of a distributor’s business.
Attorney Matthew R. Ludowig takes a practical approach to helping his clients. He has the real-world experience in the industry necessary to provide you with a knowledgeable and effective partner for your business. You need a nationwide distributors and emerging therapies lawyer who knows your business and can help you anticipate potential issues that may arise in the future.
Innova Health Law is located at 2100 West Loop South Ste 700 Houston, Texas 77027, near the intersection between of San Felipe and Highway 610 in the Uptown section of Houston. Call us today to speak to an experienced distributors and emerging therapies attorney.
Emerging therapies, and RUO / R&D products, are vital to patient care and the overall health system. These therapies have often taken many years to develop. Yet, there are many things that must happen before they can be successfully prescribed or used by healthcare providers. A distributor plays a vital role in bringing emerging therapies to fruition and the market.
What Functions Do Distributors Perform?
Distributors are responsible for bringing novel therapies from the manufacturer or developer to the patient. Their job is to manage various aspects of the pharmaceutical sales process. They often stand between the manufacturer or health care provider and the patient. Their role may be even more critical when emerging therapies are involved.
A drug developer may not have the capacity to perform the same role as the distributor. The biotech company may be focused only on developing medicines, and they need a distributor to bring successfully completed therapies to the general public.
Business Challenges Facing Distributors
Distribution is usually performed pursuant to a complex network of agreements. The distributor would need a carefully negotiated contract between themselves and other parties involved in the process. This contract must be a customized document that is carefully drafted and reviewed before it can be signed. The agreement would control all facets of the relationship between a distributor and drug developer. If anything goes wrong in the relationship, the distributor may not be paid all that they work expecting, or they could face liability from the developer or even patients.
Regulatory Challenges Facing Distributors
At the same time, the distributor is also subject to extensive oversight from regulators. This oversight occurs on numerous levels. Of course, the distributor is usually subject to FDA regulation. They may also deal with numerous state regulators. The first step is for a distributor to obtain a license from both federal and state regulators. Then, as a licensed and regulated entity, the distributor must make periodic reports to government agencies.
The consequence for failing to comply with regulations is potential enforcement action from either the state or the Federal government. The distributor’s license could be at stake. In addition, they could face enforcement action, which could result in fines. Depending on the type of therapy, there may even be a possibility of criminal charges for executives at a distributor.
Ensuring that your supply agreements with manufacturers of RUO and emerging therapies products for research include provisions for quality control, certification that they are not intended for diagnostic or therapeutic use, and that they adhere to RUO labeling conventions.
Unique Challenges in Emerging Therapy Distribution
Not only are there general threats in the distribution business, but there could also be specific challenges, depending on the type of emerging therapy. For example, an emerging therapy involving cannabis or other types of psychoactive substances involves an extra set of laws that apply at the state level that need to be followed. If the emerging therapy involves a technology, there are also intellectual property issues that must be considered.
Product Liability Issues for Distributors
A distributor must also be focused on quality control, especially when they have possession of the therapy at some point in the sales process. If a complex therapy is involved, the chain of custody must be carefully guarded. The therapy must be properly stored and handled at all times.
The distributor is considered an entity that is in the “stream of commerce.” Accordingly, they could be sued in a product liability lawsuit. If there is a defect in the emergent therapy, the distributor could be jointly and severally liable. Accordingly, a distributor needs their own policies and procedures that they must follow at all times.
How an Attorney Can Help Distributors
Given the complexity of potential legal issues that a distributor would face with emerging therapies, it is vital that they hire an attorney who understands all aspects of their business. In many ways, the attorney is a crucial part of the distributor’s risk management. A lawyer can represent a distributor in their contractual dealings with other parties, complying with regulations and protecting themselves from liability.
Our legal services also encompass advising on RUO / R&D products, including ensuring that labeling and promotional materials clearly state ‘For Research Use Only’ and avoid any clinical or diagnostic claims.
Contact a Distributors and Emerging Therapies Law Firm Today
If you are a distributor dealing with emerging therapies, speak to an experienced healthcare attorney at Innova Health Law. We can review your needs and business operations to help determine the most effective possible way to protect your legal interests. You can schedule a free consultation with a distributors and emerging therapies attorney today by filling out an online contact form or by calling us at (281) 936-9904.