FDA REGULATIONS AND LAW

FDA REGULATIONS AND LAW

Prisons fail to adequately rehabilitate offenders ...

Prisons fail to adequately rehabilitate offenders ...

FDA REGULATIONS AND LAW EXAM ESSAY QUESTIONS AND ANSWERS

Q1 

The Acu-Dot is a small, pin-head sized magnet attached to the underside of a circular, adhesive patch. It is advertised on TV and sold to the public through the internet, as well as in most grocery stores in sheets of 10 dots/patches which are packaged in a flat, cardboard box. Inside the box, in addition to the sheet of 10 Acu-Dots, can be found a four-page pamphlet purporting to be the instructions for use of the device. The back of the cardboard box states that: “An Acu-Dot is a magnetic analgesic patch for the temporary relief of occasional minor aches and pains of muscle joints.”

Each cardboard box contains 10 patches. The directions for use in the pamphlet state the following: “Apply fingertip pressure to sensitive area to determine point or points of sharpest pain or discomfort. Thoroughly clean and dry area and apply an adhesive-backed Acu-Dot to each such point.”

The mechanism of action for this product is not clear. The product sponsor claims the magnetic action draws blood to the affected area and creates a therapeutic effect. A double-blind study was conducted which compared the Acu-Dots to non-magnetized facsimiles. Of the 152 patients receiving the Acu-Dots, 138 reported some degree of pain relief. Of the 70 patients receiving the facsimiles, 20 indicated some kind of pain relief. The sponsor argued this study theoretically proved the product had a therapeutic benefit, but he could not explain its claims with acceptable empirical evidence. On the other hand, the FDA did not have any empirical evidence of the products lack of efficacy other than to rely on a “placebo” explanation from the psychological effect on the user stemming from the pain relief claims by the Acu-Dot wearers in its labeling and sophisticated marketing promotions. The FDA is not concerned with safety issues of the product but believes the product lacks efficacy.

Address the following in your answer:

  1. How is this product classified under the FDA? Why?
  2. From what source of law does the FDA get its authority to regulate this medical product?
  3. Describe the FDA regulations and requirements that would apply to the discovery, development, and commercialization approval for this product.
  4. Explain whether or not you believe that the industry sponsor of the Acu-Dot violated 21 USC Section 352?

 

Q2

Jack is a 56-year-old healthy, non-smoker, non-drinker that felt a small lump on his neck in 2017. He went to Dr. E, an ENT, who excised a small part of the lump and sent it to pathology. The pathologist, Dr. P., using the first FDA authorized whole slide imaging (WSI) system revealed atypical but non-cancerous cells. A few months later, the mass returned. Jack returned to Dr. E who determined it was scar tissue and did not re-biopsy it.

In the fall of 2019, Jack was playing basketball and was accidently hit in the throat by a teammate. His throat began bothering him and he went to a different ENT, Dr. EE, on February 6, 2020. Dr. EE noted the right neck mass as well as a right tonsil mass. That same day Dr. EE examined Jack under anesthesia and performed a direct laryngoscopy biopsy which showed invasive squamous cell carcinoma, p16+ of the right palatine tonsil which had spread to the base of his tongue and several lymph nodes in his neck.

Jack went to MD Anderson hospital in Houston, TX for treatment and rented a temporary apartment. His radiation oncologist recommended intense modulated proton beam therapy (IMPT) as medically necessary treatment which was denied by Jacks private insurance (BC/BS of Alabama). Jack’s doctor wrote a very strong 30-page expedited appeal letter, stating among other things, that reduction of radiation dose to his brainstem, brain, spinal cord, and oral cavity is imperative for reduction of toxicity and long-term side effects, which include potential for speaking and swallowing dysfunction, resulting in increased risk for aspiration and pneumonia and the eventual need for g-tube feeding. The appeal was also denied in a letter from BC/BS stating that “intense modulated photon radiation (IMRT) was the standard of care for head and neck cancer” treatment and they would only pay for that. Jack filed a third “reconsideration” claim and included several more scientific articles showing favorable results for IMPT for HPV + p16+ oropharyngeal cancers specifically including a case-controlled study that showed a 50% decrease in the need for g-tubes in patients who had IMPT versus IMRT. This last appeal was also denied. Jack was getting very anxious to start treatment as he had already been in Houston for 2 weeks waiting for a reply from his insurance company.

Read the following article and assume the additional facts below. However, any negative implications in this fact pattern re: MD Anderson are untrue as this fact pattern is hypothetical.

  1. Proton Beam Therapy (IMPT) is approved by the FDA. The insurance company denied the third appeal. The cost of proton beam therapy to Jack to pay out of pocket is $173,000 if made in one payment or $250,000 on a payment plan.
  2. Jack told his radiation oncologist, Dr. RO, that he was going to self-pay for the IMPT treatment because he read several things that indicated it is the best treatment for his specific cancer. His doctor agreed that was true but told Jack that in his honest opinion if it were him, he would not wipe out his savings and get loans for the IMPT because the IMRT treatment is also very effective. In fact, Dr. RO stated they were probably equal in terms of efficacy and survival rates. However, he did advise Jack that the long-term side effects would probably be less severe if he did the IMPT treatment based on the current medical literature.
  3. Jack was then offered to participate in a randomized clinical trial where one arm of volunteers got the IMPT and the other got the IMRT. Jack was given a consent form to sign and under the “conflicts of interest section” it states that some doctors at MD Anderson own the proton beam therapy center (IMPT) and will gain financially from its use. Assume this was the first time Jack became aware that some of the doctors on his treatment team were investors in the IMPT proton therapy center. Jack signed the consents and the hospital sent the request for payment for the clinical trial to Jack’s insurer who also denied paying for the clinical trial costs. Since his chance at getting IMPT paid for as a clinical trial participant was not approved, Jack decided he was not going to participate in the clinical trial since he would have to pay for it out of pocket and he wasn’t sure what arm he would be in. Jack was very confused and now 4 weeks had gone by without treatment.
  4. Jack decided to go with the photon therapy (IMRT) that his insurance would cover. Following 35 radiation treatments, the 3 in. mass in his neck shrunk enough that a surgeon was able to resection it and remove it. The surgeon was conducting academic research for another teaching hospital measuring variances in tissue damage in IMRT versus IMPT. He submitted what remained of Jack’s neck mass for further study. Although Jack signed general consents for the surgery, he does not remember reading anything about them retaining the mass nor agreeing to take part in this study.

Discuss all potential legal issues related to informed consents, misleading advertising, physician owned medical device companies, as well as the strength and weaknesses of potential tort remedies for Jack under bad faith claims against his insurer, products liability against WSI, and/or negligence for medical malpractice. Include an analysis of potential damages Jack could recover under each theory.