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Review Questions for Drug and Medical Device Law
Professor Richards, Fall 2002

General Exam Notes

This is an open book, open outline exam.  The exam will be a combination of short answer and short essay (1-3 pages) questions.  If you have read all the materials carefully, you will have time to check an occasional answer against the book, but you will not have time to try look everything up. 

What is a drug?

Be prepared to analyze whether something is a drug for the purposes of FDA.

Think about the Bacto-Unidisk and Home pregnancy test cases - how are they different?  How is a home test kit for HIV different from a test kit for pregnancy? What about a home test kit to find out if you kid is on drugs?  What about testing underwear to find out if your spouse is cheating?

Think about how labeling can affect whether something is a drug. Does it matter if it is the manufacturer's label?  What if it is a book by an independent author?  What about WWW sites? 

Why isn't coffee a drug?  What about nicotine lollipops? 

What is the GRASE exception and what might it apply to? 

Are placebos drugs for FDA purposes?

From idea to market

What are the FDA regulatory steps in getting a drug approved and ready to market?

What are the stage of clinical trials?

What are IRBs, what is they legal role, and how are they involved in the new drug approval process?

What is a treatment IND?

Post Market

Your client has started marketing his new drug.  What are the FDA requirements for post market surveillance? What if there are reports of side-effects?

Practice of Medicine

What are the limits to FDA regulation? 

What can docs do that drug companies cannot do? 

What are the limits to the practice of medicine exception? 

Can a doc sell drugs across state lines? 

What if his patients come from other states? 

Why does the lack of FDA authority over medical practice make it impossible to control off label use of drugs?  How is the authority of the DEA different from that of the FDA? 

Can the DEA control the prescribing by physicians?

Are there any legal ways for patients to get drugs that are approved in Europe but not in the US?

Basic enforcement tools

How do the concepts of misbranding and adulteration underlie all FDA drug regulation?

What are the FDA's basic enforcement tools and when do you use them?

What can the FDA do and not do to get a drug off the market?

Why are companies sometimes unwilling to fight the FDA even if they think they FDA has exceeded its authority?

What the rules for pulling a drug that poses an imminent hazard? Why might the FDA leave such a drug on the market for a while?

Why isn't pulling a drug off the market a taking entitling the manufacturer to compensation?

Informed consent

What are the elements of an informed consent case?

What are the different standards for what you need to tell the patient?

What is the LA rule?

What are the standards IRBs apply for consent to medical research?

Adlaw issues

What is the difference between substantial evidence as an adlaw term of art and substantial evidence as the standard for FDA review of whether a drug should be approved?

What are the grounds for challenging a federal agency action?

What is the record and why is it critical in challenges to agency decision making?

What is the standard the courts use in reviewing agency decisions on policy matters?

What is the standard for reviewing agency interpretations of law?

When and how can you sue the FDA for damages as opposed to injunctive relief and mandamus?

Medical Devices

What is the regulatory structure for medical devices and how do the risk classes fit in?

What are the preemption issues for medical devices? How is this different from drugs?

Distinguish 510(k) approval from PMA approval and explain how this effects preemption.

OTC v. Rx

What are the standards for deciding whether a drug is OTC or Rx?

What is the role of labeling?

Who can petition to change the status of a drug?

What are the pros and cons of an OTC-Rx switch?

How the legal standards for suing over labeling different for OTC and Rx drugs?

Rx Drug Labeling

What is "rational prescribing"?

Who are drug labels written for?

What is the learned intermediary and how does this change Rx vs. OTC labels?

What are off-label uses?

What are the limitations on what the manufacturer may put on drug labels?

What are the special problems with drugs for pregnant women?

May physicians give drugs for off-label uses?

Can a plaintiff use the drug label to claim that off-label uses are negligent?

What is the role of the drug label in malpractice cases against physicians?

What about the PDR?

Who has standing to contest drug labeling?

What are patient package inserts and why did physicians oppose their use?

What are the different ways drug companies use to get information to physicians?

Do physicians always read this information?

Advertising

What are the legal differences between advertising to physicians and directly to consumers?

How may drug companies legally promote off-label uses?

What are the legal risks of promoting off-label uses?

Liability for Drugs and Devices

How does strict liability differ from negligence?

What are the defenses to a strict liability claim?

What manufacturing defects?

What are design defects?

What type of claim is a failure to inform claim?

How does the learned intermediary defense protect the drug company?

What are the limits on the learned intermediary defense?

What is comment K and why is it essential to defending products cases against drug manufacturers?

What is the mass immunization exception to the learned intermediary rule?

How are the liability issues different for off-label and on-label uses?

When can drug companies argue that the label is a defense to a lawsuit about not providing adequate information to use a drug safely?

When can a drug company be in the position of having to provide safe use information for off-label uses?

What are the legal implications of direct to consumer marketing for Rx drugs?

How is the liability for physicians and pharmacies different from the liability for drug manufacturers?  Why do the courts make this distinction?

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