Tutorial Questions Week 6

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Jan 9, 2024

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Tutorial Questions Week 6 TQ 6.1: Hyman, Phelps, and McNamara: How did the 2007 amendments expand participation in the clinical trial registry database? On what basis can the FDA now require postmarket studies or clinical trials? What are the penalties for violation of the new statutory provisions for REMS and new safety information? - The FDAAA requires the responsible party of applicable clinical drug or device trials to submit information regarding the trial to NIH for inclusion in the clinical trial registry database. The 2007 amendments expanded participation in the database to include trials for all diseases and conditions, expanded information available on the trial, and adding clinical trials of medical devices. - The FDA can require post-market studies or clinical trials on the basis of scientific data deemed appropriate, which includes information regarding chemically related or pharmacologically related drugs. The studies would be used to assess a known serious risk or signals of risk related to the drug, or to identify an unexpected serious risk when data indicates potential. - The penalties for violating REMS or new provisions include: a drug being deemed misbranded under FDC Act §502; a civil penalty capped at $250,000 per violation with a max of $1,000,000 for all violations in a single occurrence; additional penatlies assessed if the violation is not ended immediately upon notice, which would make the responsible party subject to an additional $250,000 for the next 30-days with an increase to $500,000 for the next subsequent 30-days and $1,000,000 for anytime after, capped at $10 million in a single occurrence. Food and Drug Administration Amendments Act of 2007 TQ 6.2: Matrixx: What was the role of the adverse event reports in claims of securities fraud? What is the “bright-line rule” urged by Matrix? - The plaintiffs filed a class action for securities fraud based on the defendants’ failure to disclose reports of adverse events and lawsuits associated with their highest valued product to mislead their investors. The “bright-line rule” urged by the Matrixx would limit the available information to be considered significant to the trading decision of a reasonable investor. The rule would be that reports of adverse events associated with a pharmaceutical company’s products cannot be absent a sufficient number of such reports to establish a statistically significant risk that the product is in fact causing the event. Matrixx Initiatives, Inc., v. Siracusano et al. 131 S.Ct. 1309 (2011) TQ 6.3: Using a Drug Safety Tool to Prevent Competition: How have brand-name manufacturers attempted to use REMS systems to prevent the entry of generic competition? - Brand-name manufacturers have attempted to block generic competition by invoking the system for refusing to supply their products to the generic drug companies for the studies needed to establish bioequivalence. The REMS system would essentially prevent the
brand-name from distributing samples of their drug or any information pertaining to the drug to their competitors. Another method used is to patent their REMS program. This is done by brand-name manufacturers describing their programs as innovative methods of safely distributing dangerous drugs that are new and useful methods of conducting business. Using a Drug Safety Tool to Prevent Competition
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