Lecture 4 part 4

Question 1

The FDA Modernization Act of 1997

Allowed manufacturers to distribute info re:
unapproved drug indications to health care
professionals if:
a. NDA approved before for drug; b. information was submitted to FDA 60 days in advance of distribution; and

c. manufacturer discloses info and indication
not FDA-approved, and any potential conflicts
of interest.

Question 2

The FDA Modernization Act of 1997

Provides exemption from the requirement to submit a supplemental NDA for a new indication when circumstances indicate (ex:When its already been used for that for years and nobody no one has a patent on it it anymore)

Allows exemption for the provision of investigational devices or drugs to patients with serious life-threatening illnesses (ex: can still continue to get drug that is not approved by fda yet because pts were in the study)

Question 3

The Food and Drug Administration
Amendments Act (FDAAA) of 2007

Gave the FDA broader use of PDUFA fees

Gave FDA post-marketing powers:
– Can mandate _________related to safety
– Require clinical trial data reporting and
registries
– Require post-market clinical studies to assess
safety
– Require risk evaluation and mitigation
strategies (________) when deemed necessary

Answer 3

labeling changes, clinical trial, post market, REMS

Question 4

REMS are required information you have to give the pt

Question 5

Obamacare aka patient protection and affordable care act–>save the average consumer of health insurance $2,500 a year instead it did just the opposite it…health insurance went up about $2,500 a year for the average consumer but it provided access to people with Medicaid to people who didn’t qualify for it otherwise they might have to pay for it but they can get Medicaid coverage at a lower cost than say private insurance

Question 6

Patient Protection and Affordable Care
Act of 2010

Does not directly impact on the FDCA; however,
several provisions:
– Create a role for FDA representatives in several
new federal entities concerning healthcare, and
– Require compliance with all FDA laws and
regulations in the establishment of any law or
regulation concerning drugs or medical devices. (The FDA nor anybody else could create laws and regulations that were not in compliance with the existing federal law)

Question 7

Before Affordable Care Act 30 million people did not have any sort of health care insurance

Question 8

FDA Safety and Innovation Act of 2012

Reauthorized the sunsetting PDUFA
– Added manufacturer fees for generic drug and
biosimilar approvals

Has provisions directed at reducing counterfeiting, blocking adulterated product
imports, detecting and reducing drug shortages,
and enhancing drug diversion data across state
lines

Enables FDA to inspect _________drug
manufacturing facilities more regularly (can’t stop them from exporting to the US but can’t shut it down

Answer 8

foreign

Question 9

Drug Quality and Security Act (DQSA) of 2013

Created legal authority for FDA licensing and
regulation of outsourcing facilities, distinguishing
them from compounding pharmacies.

Established a fee schedule for outsourcing
facilities.

Creates law to better regulate and secure the
drug supply chain in the United States –
attempting to reduce counterfeiting and
diversion.

Question 10

Outsourcing facilities only deal in sterile products

Question 11

Outsourcing facilities Sell to other hospitals and not consumers or patients

Question 12

Outsourcing facilities have to pay a fee to the FDA and have to be inspected by FDA

Question 13

FDA constantly wants to interfere with compounding even though its the state board of pharmacy responsibility