Detailed Flashcards FDA - Exam 1

What did the FDA of 1906 forbid? (or stop)

The FDA of 1906 forbade interstate and foreign commerce in adulterated and misbranded food and drugs.

(stopped selling fake or mislabeled food and drugs across states or countries.)

What could happen to offending products under the FDA of 1906? (bad products)

Offending products could be seized and condemned (destroyed)

(Bad products could be taken and destroyed_

What could happen to offending persons under the FDA of 1906?

Offending persons could be fined and jailed.

What part of the U.S. Constitution did the FDA of 1906 use for its authority?

It used the interstate commerce clause.

What standard did drugs have to meet under the FDA of 1906?

Drugs had to meet standards of strength and purity.

What set the standards for drug strength and purity?

Standards were set by the United States Pharmacopoeia (USP) or by the manufacturer based on the label.

What was the miracle drug involved in the 1937 disaster?

Sulfanilamide was the miracle drug used to prevent infections

How was the medicine turned into a liquid? (1937 disaster)

The manufacturer mixed it with diethylene glycol, a toxic chemical found in antifreeze.

What was the deadly mistake made with the medicine? (1937 disaster)

The liquid medicine was made with diethylene glycol, which is highly toxic and caused deaths.

Was the medicine tested for safety before being sold? (1937 disaster)

No, it wasn’t tested, so no one knew it was dangerous.

What was the tragic outcome of this disaster? (1937 disaster)

107 people died, leading to public outrage and calls for stronger safety rules

What did the 1937 disaster lead to?

It pushed the government to create stricter rules for drug safety.

What did the FDA of 1938 assume about drugs?

It assumed that all drugs could be harmful if not used correctly.

What was required for new drugs under the FDA of 1938?

New drugs had to be tested for safety before being sold and show if they caused any diseases.

What did drug labels need to include under the FDA of 1938?

Labels had to include clear instructions on how to use the drug properly

have a warning label indicating they could be addictive

Were old drugs affected by the FDA of 1938?

No, drugs already on the market before 1938 were exempt from the new rules

What was the main purpose of the FDA of 1938?

The FDA of 1938 made drug safety a priority, ensuring drugs were tested, had clear directions, and included necessary warnings.

What did the Durham-Humphrey Amendment define?

it defined which drugs are too dangerous to use without a doctor's guidance.

What did the Durham-Humphrey Amendment require for these drugs?

These drugs could only be sold if a licensed doctor prescribed them.

What event led to the Kefauver-Harris Amendment of 1962?

The Thalidomide Scare, where a sleeping pill caused birth defects in babies in Western Europe.

What did the Kefauver-Harris Amendment do after the Thalidomide scare?

It created stronger rules to ensure drugs are both safe and effective before being sold.

What was the main purpose of the Kefauver-Harris Amendment?

To protect people by requiring drug companies to show their products are both safe and effective before they can be sold.

What did drug companies need to prove under the Kefauver-Harris Amendment?

They had to prove to the FDA that their drugs were effective as well as safe.

What did manufacturers have to do under the Medical Device Amendments?

Manufacturers had to register with the FDA and follow strict quality control procedures to ensure safety.

Did all medical devices need FDA approval? (medical Device Amendments)

Some devices had to get FDA approval before being sold, while others needed to meet specific performance standards.

What was the main goal of the Medical Device Amendments?

To ensure medical devices were safe and effective by requiring companies to register, follow quality rules, and get approval before selling certain products.

What is the purpose of the Orphan Drug Act of 1983?

It encourages companies to develop drugs for rare diseases by offering incentives like market exclusivity and tax benefits.

How long does a company have exclusive rights to sell an orphan drug under the Orphan Drug Act?

7 years of exclusive rights to sell the drug without competition (market exclusivity)

What tax benefits do companies get under the Orphan Drug Act?

Companies receive tax credits to cover 50% of their research and development costs for orphan drugs.

What defines an orphan drug?

A drug that treats a disease affecting fewer than 200,000 people in the U.S., or one where the company can’t make enough money to recover development costs.

What did the Hatch-Waxman Act of 1984 make easier?

It made it easier for cheaper generic drugs to become available by allowing faster approval.

How did the Hatch-Waxman Act speed up the approval of generic drugs?

It allowed the FDA to approve generic drugs without requiring companies to repeat expensive safety and effectiveness tests already done for brand-name drugs.

What benefit did brand-name drug companies get under the Hatch-Waxman Act?

They could apply for up to 5 extra years of patent protection to keep their exclusive rights to sell the drug before generics could enter the market.

What was the main goal of the Hatch-Waxman Act?

To make generic drugs available faster and cheaper, while giving brand-name companies extra time to protect their patents.

What did the Prescription Drug User Fee Act (PDUFA) of 1992 require drug companies to do?

It required drug and biologic manufacturers to pay fees when they applied for product approval or submitted updates.

Based on PDUFA of 1992, How did the FDA use the fees from PDUFA?

The FDA used the fees to hire more reviewers to look at the applications faster.

What was the main goal of the Prescription Drug User Fee Act?

To allow the FDA to speed up drug approvals by using fees from companies to hire more staff and improve efficiency.

What did the Dietary Supplement Health and Education Act (1994) establish?

It established specific labeling requirements for dietary supplements

What framework did the Dietary Supplement Health and Education Act provide?

provided a regulatory framework for dietary supplements.

What authority did the Dietary Supplement Health and Education Act give the FDA?

It authorized the FDA to create good manufacturing practice regulations for dietary supplements.

What did the FDA Modernization Act (FDAMA) of 1997 reauthorize?

It reauthorized the Prescription Drug User Fee Act (PDUFA).

What major reforms did the FDAMA of 1997 mandate?

It mandated reforms to accelerate review of devices, regulate advertising of unapproved uses, and regulate health claims for foods.

What did FDAMA allow manufacturers to do regarding off-label drug use?

It allowed manufacturers to disseminate peer-reviewed journal articles about off-label use, provided the company filed a supplemental application based on research to prove safety and efficacy.

What special exemption did the FDAMA of 1997 provide?

it gave a special exemption to ensure the continued availability of compounded products prepared by pharmacists.

How did the FDAMA increase patient access to experimental drugs?

it allowed increased patient access to experimental drugs.

What did FDAMA do regarding clinical trial databases?

It allowed an expanded database on clinical trials to be accessible to patients (with manufacturer consent).

How did FDAMA address the issue of drug discontinuation?

It provided a method of notifying patients if a drug needed for treatment was no longer going to be produced.

What is the purpose of the Public Health Security and Bioterrorism Preparedness and Response Act (2002)?

To protect the safety and security of human drugs, biologics, medical devices, veterinary drugs, and other FDA-regulated products.

What major law was reauthorized by the Public Health Security and Bioterrorism Preparedness and Response Act (2002)?

The Prescription Drug User Fee Act (PDUFA) was reauthorized.

What new commitments were made by the Public Health Security and Bioterrorism Preparedness and Response Act (2002)?

The law committed to more ambitious and comprehensive improvements in the regulatory process.

How did the Public Health Security and Bioterrorism Preparedness and Response Act (2002) strengthen drug safety?

It aimed to strengthen and improve the review and monitoring of drug safety

How did the act improve the review process for serious and life-threatening drugs?

It called for greater interaction between the FDA and sponsors during the review of these drugs.

What principle did the Public Health Security and Bioterrorism Preparedness and Response Act (2002) develop to improve drug reviews?

It focused on developing principles for improving first cycle review of drugs.

What did the Public Health Security and Bioterrorism Preparedness and Response Act (2002) do to speed up drug development?

authorized fees to be dedicated toward expediting the drug development process and reviewing human drug applications faster.

What happens if a manufacturer fails to comply with post-marketing studies?

FDA will post the failure on its website, and clinicians who prescribe the drug will be informed.

What is the purpose of the Medical Device User Fee Modernization Act (2002)?

To apply the same structure used for prescription drugs to medical devices by utilizing user fees from the industry.

How did the Medical Device User Fee Modernization Act (2002) impact the approval process for medical devices?

It allowed for the collection of user fees from the medical device industry to help speed up the review and approval process, similar to prescription drugs

What does the Medical Device User Fee Modernization Act (2002) use to fund the FDA's medical device approval process?

uses user fees paid by the medical device industry

Which industry's fees were used in a similar way to prescription drugs, according to the Medical Device User Fee Modernization Act (2002)?

The medical device industry's fees were used in the same way as the prescription drug industry’s fees.

What is the purpose of the Animal Drug User Fee Act (2003)?

It applies the same structure used for prescription drugs and medical devices to animal drugs, allowing fees from the industry to pay for additional testing.

How does the Animal Drug User Fee Act (2003) fund the testing of animal drugs?

uses fees from the animal drug industry to fund additional testing

What industry’s fees are used for additional testing of animal drugs, according to the Animal Drug User Fee Act (2003)?

animal drug industry’s fees are used to fund additional testing

Which act applied the same fee structure as for prescription drugs and medical devices to animal drugs?

Animal Drug User Fee Act (2003).

What does the Pediatric Research Act (2003) give the FDA the authority to do?

gives the FDA additional authority to require pediatric studies of pharmaceutical products to ensure their safe and effective use in children.

Why can the FDA require pediatric studies of pharmaceutical products under the Pediatric Research Act (2003)?

the FDA can require these studies when they are needed to ensure the safe and effective use of products in children.

What is the Best Pharmaceuticals for Children Act (BCPA) of 2002?

it extended marketing exclusivity for studies requested by the FDA on pediatric uses of drugs.

What does the Pediatric Research Act (2003) help ensure for children?

helps ensure the safe and effective use of pharmaceutical products in children by requiring specific pediatric studies.

hat did the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) require regarding serious adverse events?

required serious adverse event reporting for both nonprescription drugs and dietary supplements.

What type of adverse event reporting did the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) add?

added reporting for serious adverse events related to nonprescription drugs and dietary supplements.

What does the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) prohibit?

prohibits the falsification of serious adverse event reports related to nonprescription drugs and dietary supplements.

How did the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) affect the importation of products?

it tightened regulations regarding the importation

What important acts did the FDAAA of 2007 reauthorize? (2)

reauthorized PDUFA (Prescription Drug User Fee Act) and the Medical Device User Fee and Modernization Act.

What pediatric-related acts were reauthorized under the FDAAA of 2007?

reauthorized the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

What new power did the FDAAA of 2007 give the FDA regarding TV advertisements?

allows the FDA to review Direct-to-Consumer (DTC) television ads that are voluntarily submitted.

How did the FDAAA of 2007 help FDA reviewers?

It expanded FDA’s implementation of guidance for reviewers to improve the review process.

What new authority did the FDAAA of 2007 grant the FDA concerning clinical trials?

allowed the FDA to develop guidelines on clinical trial design.

How did the FDAAA of 2007 affect the FDA’s approach to technology?

helped move the FDA and industry toward an all-electronic environment

How did the FDAAA of 2007 streamline device inspections?

allowed accredited outside firms to conduct routine inspections for Good Manufacturing Practices (GMP)

What focus did the FDAAA of 2007 have for device inspection resources?

focused the FDA’s device inspection resources on high-risk products and production facilities

What electronic system did the FDAAA of 2007 call for the FDA to create?

It called for the FDA to set up an electronic surveillance system using e-health records and electronic health data sources to monitor adverse events

How did the FDAAA of 2007 impact clinical trial data?

It expanded the government database on clinical trials, making it more accessible

What labeling and study-related powers did the FDAAA of 2007 grant the FDA?

It allowed the FDA to add warnings to labels and require post-marketing studies for certain products.

What power did the Family Smoking Prevention and Tobacco Control Act give the FDA?

It gave the FDA the ability to regulate the tobacco industry and stop tobacco companies from aggressively marketing to children

What does the Family Smoking Prevention and Tobacco Control Act require for new tobacco products?

requires the FDA to review new tobacco products before they can go to market unless they are similar to products marketed before February 15, 2007

What advertising restrictions does the Family Smoking Prevention and Tobacco Control Act allow the FDA to enforce?

allows the FDA to enforce restrictions on advertising and promotion of menthol and other cigarettes to minors.

What major law is the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) a part of?

It is part of the Patient Protection and Affordable Care Act.

What does the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allow for biological products?

It allows for an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar or interchangeable with an FDA-approved biological product.

What are biologics?

Biologics are large, complex molecules produced in living species (microorganisms, plant cells, animal cells) using recombinant DNA technology.

What are some examples of biologics used in medicine?

Biologics are used to treat, prevent, or cure diseases and medical conditions, including therapeutic proteins, vaccines, blood and blood components, allergenic products, and monoclonal antibodies

What is the definition of biosimilars?

Biosimilars have no clinically meaningful difference in terms of safety, purity, potency, and they are the same type of sources, administered the same way, with the same strength, dosage, potential treatment effects, and potential side effects as the reference product.

What does it mean for a biosimilar to be interchangeable?

A biosimilar is considered interchangeable if it can be substituted for the reference product without the intervention of the prescribing healthcare provider (if state law allows)

What legislative mandate did the FDA Food Safety Modernization Act (2010) give the FDA?

The FDA Food Safety Modernization Act (2010) gave the FDA the mandate to require comprehensive, prevention-based controls across the food supply, including imported foods.

What areas does the FDA Food Safety Modernization Act (2010) regulate?

The FDA Food Safety Modernization Act (2010) regulates inspection and compliance issues related to food safety

What authority does the FDA Food Safety Modernization Act (2010) give the FDA regarding food products?

The FDA Food Safety Modernization Act (2010) gives the FDA mandatory recall authority for food products.

When was the Food and Drug Administration Safety and Innovation Act (FDASIA) signed?

The FDASIA was signed on July 9, 2012

What authority did the FDASIA give the FDA regarding user fees?

The FDASIA gave the FDA the authority to collect user fees for innovator drugs, medical devices, generic drugs, and biosimilar biological products

How did the FDASIA promote innovation?

speeding up patient access to safe and effective products

How did the FDASIA increase stakeholder involvement?

The FDASIA increased stakeholder involvement in the FDA processes.

What aspect of the drug supply chain did the FDASIA enhance?

The FDASIA enhanced the safety of the drug supply chain