(After pg 4 of outline)Law Outline Drug development and regulation of new products

Question 1

NDA vs ANDA Review Process

Answer 1

Question 2

Controversies

Answer 2

1. Health care providers
2. Drug Manufacturers
3. Section 505(b)(2) NDA

Question 3

Controversies

1. Health care provider

Answer 3

1. Treatment differences- law allows generic to statistically vary in rate and extent of absorption by + 20% from innovator drug. There could be up to a 40% difference in blood level between a generic and innovator in the course of 2 months of therapy, resulting in adverse clinical outcomes.
   
   1. Data analysis of generic and innovator drugs- average difference is 3.5%, which shouldn’t produce clinical differences.
2. Whether generic can be dispensed for indication that the innovator had been granted market exclusivity?
   
   1. Answer- yes; ex: generic propranolol for post-MI, when innovator brand propranolol has marketing exclusivity for this condition. This would be use of an approved drug for an off-label use
3. But, can FDA approve ANDA for generic drug when the labeling of the generic drug won’t include all conditions/indications listed for innovator drug?
   
   1. Yes- generic labeling can still be effective and safe without all listed indications
   2. And, because new generic drugs could be delayed- innovator drug manufacturers could strategically file for supplemental indications every three years to delay generic manufacturing.

Question 4

Controversies

2. Drug Manufacturers

Answer 4

2. Drug Manufacturers
3. “Authorized generics” innovator drug manufacturer will produce a generic version of brand name product just as patent is about to expire or be successfully challenged.
   
   1. Innovator may do with without an ANDA
4. 30 month stay in ANDA approval when patent holder sues generic for patent infringement- many manufacturers sue to obtain the 30 month exclusivity even though they have very weak legal positions and little chance of prevailing.
5. Secondary patents that cover manufacturing processes, methods of use, and new tablet coatings
6. “product hopping”- when patent nears the end, manufacturer will change product- extended release, different salt, to secure additional patent
7. Pay for delay- innovator will pay generic company not to market generic

Question 5

Controversies

3. Section 505(b)(2) NDA:

Answer 5

3. Section 505(b)(2) NDA: manufacturer is allowed to rely, at least in part, on published safety and efficacy data, and/or the FDA’s findings for a previously approved drug, reducing the number of clinical trials required. This is NDA route so it includes 3-5 years of market exclusivity
4. Reasons for filing 505(b)(2) application:
   1. Manufacturer of a drug approved under previous NDA might use this pathway to receive approval for new indications, relying on the safety data of previous NDA
   2. Generic manufacturer might use this pathway instead of a full NDA when the generic product can’t be approved under an ANDA because of significant changes from the reference product in terms of different formulation, route of administration, or delivery mechanism

Question 6

OTC review

1. After prescription drugs review under DESI, FDA began reviewing OTCs marketed between 1938 and 1962. Different review system for OTC.

Answer 6

1. Evaluates based on therapeutic categories and classifies products through rule making rather than individually.- Nearly all OTCs had been prepared from only about 200 active ingredients.
2. Procedure-
   
   1. FDA appointed advisory review panel of qualified experts to consider drugs by class (analgesic, antacids, etc.) and to make recommendations
   2. FDA publishes recommendations in Federal Register, requesting public comment
   3. After comments, FDA publishes a proposed rule in Federal Register.
   4. FDA publishes monograph, identifying which active ingredients are generally recognized as safe and effective and may therefore be marketed. Monograph specifies labeling.
      
      1. Products that do not contain approved active ingredients or labeling must be removed and where possible reformulated and relabeled.
   5. Monograph on reviewed ingredients specifies in which of three categories the ingredient is placed:
      
      1. Cat I- generally recognized as safe, effective, and not misbranded
      2. II- not generally recognized as safe and effective or that are misbranded
      3. III data available are insufficient to permit classification

Question 7

Medwatch Program

Answer 7

1. FDA maintained voluntary reporting program- MedWatch
   
   1. Health care professionals to report any serious adverse events, potential and actual product use errors, and product quality problems related to drugs, biologics, medical devices, special nutritional products and cosmetics.
   2. Official reporting form available: http://www.fda.gov/Safety/MedWatch/
      
      1. Available information for safety alerts- practice tip!
   3. Pharmacy requirement to provide patients with medwatch number- FDAAA broadened the program to include patient reporting.
      
      1. Pharmacies must provide patients with a notification of a toll-free number so they can report adverse events on new and refills.
         
         1. Call you doctor for medical advice about side effects. You may report side effects to the FDA at 1800 FDA- 1088.
            
            1. Sticker attached to the container or package
            2. On preprinted vial cap
            3. On separate piece of paper
            4. In patient medication information distributed by pharmacy
            5. In MedGuide

Question 8

Marketing unapproved drugs

Answer 8

NOT ALL MARKETED DRUGS HAVE BEEN APPROVED BY THE FDA

FDA estimates that as many as several thousand prescription and OTC drug products are marketed illegally without approval. Why? How?

1. Until DESI was instituted in 1968, FDA had a policy of allowing post 1938 generics to be marketed as not new drugs if the pioneer or innovator drug had a safe marketing history
   
   1. During this time, FDA allowed some drugs to be marketed that were not identical or similar to other marketed drugs, FDA felt they were not new drugs/or because agency didn’t take action against them
2. Some drugs are still being reviewed under desi- FDA has allowed them to be marketed while pending review
3. Some drugs have been determined to lack efficacy after DESI review, but haven’t yet been removed from market
4. Some drugs marketed claim to be grandfathered as pre-1938 drugs, but have changed their labeling or composition, thus voiding their exempted status
5. Some drug manufacturers market product without approval, hoping to escape notice as long as possible
6. Illegally marketed OTCs either because monographs don’t allow ingredients, or because never subject to OTC DESI review.

Will remain on market-

Have to be identified, then legally removed- investment of time and resources

Prioritized: enforcement of drugs

Safety risk

Those that lack evidence of effectiveness,

Those that involve health fraud

Question 9

Drugs Intend to Treat Serious Life Threatening Diseases

Answer 9

1. Patient treatment with investigational drugs
2. Individual patient access to investigational drugs for serious diseases
3. FDA Expanded Access Program
4. State and federal right to try laws (Arizona)

Question 10

1. Patient treatment with investigational drug

Answer 10

1. FDAMA modified FDCA to state that an investigational drug may be provided for widespread access outside controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory alternative therapy is available. FDA will approve treatment only IF
   
   1. Used for serious or immediately life threatening disease or condition
   2. There is no comparable or satisfactory alternative therapy available
   3. The drug is under investigation for the disease or condition
   4. The sponsor is actively pursuing marketing approval of the drug
   5. In the case of serious diseases, there is sufficient evidence of safety and effectiveness for use
   6. In the case of immediately life-threatening diseases, there is a reasonable basis to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk.

Question 11

2. Individual patient access to investigational drugs for serious diseases

Answer 11

1. FDAMA provides that an individual acting through physician may request an investigational drug from manufacturer if
   
   1. Patient has no comparable satisfactory alternative therapy
   2. And the risk to the patient from the drug is no greater than the risk from the disease or condition
2. FDA must determine that there is sufficient evidence of safety and effectiveness to support its use and that the individual’s use will not interfere with clinical investigations.
3. Sponsor must submit protocol describing drug use
4. Originally restricted to Phase 3 drugs, but new regulations passed after and during litigation permit potential access to even phase 1 drugs.

Question 12

3. FDA Expanded Access Program

Answer 12

permits patients with life-threatening diseases or conditions who have exhausted approved treatment options to seek access (through their treating physician) to experimental drugs even in Phase I. Also expands and clarifies the treatment use of experimental drugs

1. Biggest barriers- FDA cannot compel drug manufacturers to provide IND drugs and many have refused to provide the drugs because of a limit supply, safety concerns because of the limited testing, or fear that an adverse event will ultimately jeopardize the drug’s approval.

Question 13

4. State and federal right to try laws (Arizona)

Answer 13

1. FDA contends it has approved 99% of the 5,800 applications for IND drug treatment under expanded access.
2. About 30 states (including Arizona) have passed right to try laws that allow patient to go directly to manufacturer and bypass the FDA. However, manufacturer is not obligated to provide the drug, and a patient’s insurance may withhold coverage for care if a patient takes an unapproved drug
3. Federal right to try amends the FDCA by creating an alternative pathway to investigational new drugs by removing the FDA from the process. Some patients may choose to still apply through the FDA

Question 14

biologics

Answer 14

1. Products derived from living organisms, and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, and blood components, and derivatives applicable to the prevention, treatment, or cure of a disease or condition of humans.
2. Regulated under Public Health Service Act and FDCA.
3. ACA (Affordable Care Act) 2010, created a regulatory framework to approve generic biologics or biosimilars. Biologics Price Competition and Innovation Act (BPCIA)- creates a regulatory framework to facilitate the approval of generic biologics (biosimilars)

Question 15

biologics

2. Regulated under Public Health Service Act and FDCA.

Answer 15

1. Require premarket approval by FDA and subject to FDCA requirements like new drug products, they are licensed under Public Health Service Act.
   
   1. FDA will approve a license upon demonstration that the product is safe, pure, and potent, and that the manufacturing facility meets required standards.

Question 16

biologics

3. ACA

Answer 16

3. ACA (Affordable Care Act) 2010, created a regulatory framework to approve generic biologics or biosimilars. Biologics Price Competition and Innovation Act (BPCIA)- creates a regulatory framework to facilitate the approval of generic biologics (biosimilars)
4. Grants FDA authority to determine whether a biosimilar is therapeutically equivalent to a reference biologic and thus can be substituted in the same manner as generic drugs.
5. Controversial- since manufacturing process of biologics is complex and innovating.
6. Purple book- lists biological products including any biosimilar and interchangeable biologic products licensed by FDA

Question 17

Medical Devices

Answer 17

1. Medical Device Act of 1976, amends FDCA to establish a comprehensive system of device regulation that establishes classification system, requires premarket testing, and standards of performance.
2. Certain devices may only be available by prescription
3. Custom devices
4. Manufacturers must report to the FDA any death or serious injury that may be related to their products. If
5. Device user facilities must report to Secretary of Health and Human Services any death, serious injury, or serious illness that may be related to the product (Safe Medical Devices Act of 1990).

Question 18

medical devices

1.

Answer 18

1. Devices marketed before the Act (pre-amendment devices) were permitted to remain on the market pending classification or other type of FDA action
2. Post amendment devices fall within one of three classifications (and FDA can reclassify devices; if manufacturer successfully petitions for reclassification, the reclassification applies to the generic as well):
   
   1. Class I: least regulation; pose least potential harm; general controls are adequate to ensure safety and effectiveness.
      
      1. General controls: require that device manufacturers register their facility and list their products with FDA, provide pre-market notification in some cases, maintain records and reports and adhere to good manufacturing practices.
      2. EX: needles, scissors, examination gloves, stethoscopes, and toothbrushes.
   2. Class II: General controls alone are insufficient to ensure safety and effectiveness. Must meet specific performance standards before FDA will permit marketing
      
      1. EX: insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, and electric heating pads.
   3. Class III: must have pre-market approval because they are life supporting or life sustaining or they present potential unreasonable risk of illness or injury
      
      1. EX: Pacemakers, soft contact lenses, replacement heart valves.
      2. Any device not marketed before 1976 initially falls into class III unless the FDA determines that they are substantially similar to a class I or class II device.

FDA can reclassify devices

Question 19

medical devices

2. certain devices may only be available by prescription

Answer 19

2. Certain devices may only be available by prescription- these are devices that have a potential for harm or require collateral measures to ensure their proper use.
3. Ex: diaphragms, contact lenses

Question 20

medical devices

3. custom devices

Answer 20

3. Custom devices- ordered for specific needs of individual patients (like orthopedic footwear) are generally exempt from some requirements such as registration, performance standards, and premarket approval. But, conforming to good manufacturing practices and the adulteration and misbranding requirement apply.

Question 21

Medical devices

4. Manufacturers must report to the FDA any death or serious injury that may be related to their products. If the FDA determines that a device presents an unreasonable risk of substantial harm, it may require the manufacturer to notify all health care professionals or to recall the product, FDA can also seize devices, enjoin shipment and withdraw approval. FDA may also require the manufacturer to:

Answer 21

4. Manufacturers must report to the FDA any death or serious injury that may be related to their products. If the FDA determines that a device presents an unreasonable risk of substantial harm, it may require the manufacturer to notify all health care professionals or to recall the product, FDA can also seize devices, enjoin shipment and withdraw approval. FDA may also require the manufacturer to:
5. Repair the devices
6. Replace the device
7. Refund the purchase price of the device.

Question 22

medical devices

5. Device user facilities must report to Secretary of Health and Human Services any death, serious injury, or serious illness that may be related to the product (Safe Medical Devices Act of 1990).

Answer 22

5. Device user facilities must report to Secretary of Health and Human Services any death, serious injury, or serious illness that may be related to the product (Safe Medical Devices Act of 1990).
6. Hospitals, ambulatory surgical facility, nursing home, or outpatient treatment facility that is not a physician’s office
7. Distributors used to have to notify, but under FDAMA removed the requirement, but distributors still must maintain records of adverse events.

Question 23

Cosmetic

Answer 23

FDCA regulates cosmetics, which do not have the same legal requirements that drugs and devices have.

1. No premarket approval, although manufacturers must substantiate the safety of their cosmetic products and each of its ingredients.
   
   1. If substantiation of the safety is not available, the display of the product must contain:
      
      1. “Warning- the safety of this product has not be determined” or the product will be considered misbranded
2. No conformance to good manufacturing practices or registration with FDA
3. FDA can remove cosmetic from the market if it is misbranded or adulterated or determined to be a health hazard
   
   1. Misbranding- if labeling is false, misleads the consumer or lacks required information, or if the label information is not clear enough to be read and understood by ordinary consumer. Or if packaging and labeling do not conform to Poison Prevention Packaging Act
   2. Adulteration
      
      1. It contains poisonous or deleterious substances that may injure user
      2. Contains any filthy, putrid, or decomposed substance
      3. It was prepared under unsanitary conditions
      4. Container contains a substance that may contaminate the contents
      5. It contains an unsafe color additive but is not a hair dye
4. Labeling requirements
   
   1. List of ingredients in descending order of predominance
      
      1. On the outside of the packaging or contain so that consumer can read at time of purchase
   2. Some cosmetics must have specified warning statements
      
      1. Ex. Pressurized containers

Question 24

Drug Advertising and Promotion

Answer 24

1. Enforcement
2. First Amendment right to free speech-
3. Prescription drug advertising:
4. OTC advertising by manufacturers
5. Food

Question 25

Drug Advertising and Promotion

1. Enforcement a

Answer 25

1. Two agencies responsible for drug advertising:
   
   1. FDA- regulates prescription drug advertising under the FDCA (15 U.S.C. § 352(n)
   2. Federal Trade Commission FTC (in collaboration with FDA) regulates nonprescription drugs under the Federal Trade Commission Act (15 U.S.C.§ 45)
2. Private parties: Lanham Trademark Act (15 U.S.C. § 1125) allows private parties a cause of action against false and misleading advertising- at that state level most pharmacy practice acts prohibit pharmacists from false, misleading or deceptive advertising. A.R.S. § 32-1901.01(A)(29)

Question 26

Drug advertising and Promotion

2. First Amendment right to free speech-

Answer 26

1. Government regulation of speech creates a legal question in relation to guaranteed rights under 1^st Amendment
   
   1. Commercial speech- promotional activities by product sellers is governed by Central Hudson test
      
      1. Speech must not be misleading or related to unlawful activity
      2. Government interest in the regulation must be substantial
      3. Regulation must directly advance the government interest asserted
      4. The restriction cannot be more extensive than necessary to serve the interest
   2. Drug advertising is commercial speech, so questions are what advertising, what manner, and to what extent

Question 27

Drug Advertising and Promotion

3. Prescription drug advertising:

Answer 27

1. Advertising Manufacturers to Professionals
2. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers
3. Promoting prescription drugs for off label use (Area of biggest concern to FDA)

Question 28

Drug Advertising and Promotion

3. Prescription drug advertising:
   a. Advertising Manufacturers to Professionals
   i. Law
4. FDCA section 502

Answer 28

1. FDCA section 502(n) provides that a drug shall be deemed misbranded unless the manufacturer includes in all advertisements and other descriptive printed matter issued a true statement of
   
   1. The established name of the drug
   2. The formula showing quantitatively each ingredient
   3. A brief summary of other information relating to side effects, contraindications, and effectiveness
   4. True statement:
      
      1. Is not false or misleading
      2. Is a fair balance between side effects and contraindication information and effectiveness information
         
         1. Same scope, depth, and detail of information
      3. Reveals material facts

Question 29

Drug Advertising and Promotion

3. Prescription drug advertising:
   a. Advertising Manufacturers to Professionals
   i. Law
4. regulations

Answer 29

2. Regulations- substance of information to be included, and the manner (size of font, order of information)
3. Exceptions-
   1. reminder advertising- those which call attention to the name of the drug product but do not include indications or dosage recommendations for use of product (21 C.F.R. §202.1(e)(2)(i)
   2. advertisements of bulk sale drugs (drugs intended to be processed, manufactured, or repackaged) or prescription compounding drugs (drugs intended for use in compounding by pharmacists) as long as no safety or effectiveness claims are made.

Question 30

Drug Advertising and Promotion

3. Prescription drug advertising:
   a. Advertising Manufacturers to Professionals
   ii. Advertising includes…

Answer 30

ii. Advertising includes journal and other periodical ads, media ads, telephone communications.

1. Brochures, booklets, mailing pieces, bulletins, calendars, price list, references and other such information disseminated by manufacturer for use by health care professionals are considered labeling.
   
   1. Advertising only contain brief summary of risks
   2. Labeling must include the entire package insert
   3. Media advertising- only major risks, provided manufacturer makes adequate provision for the dissemination of the approved package labeling.

Question 31

Drug Advertising and Promotion

3. Prescription drug advertising:
   a. Advertising Manufacturers to Professionals
   iii. Industry sponsored educational programs distinguished from promotional programs

Answer 31

1. Concern- objectivity of some manufacturer supported educational programs and the inducements that were being offered for attendance
2. Final Guidance on Industry Supported Scientific and Educational Activities (Guidance only not regulation)
   
   1. Distinguish between educational activities that are independent from promotional influence
   2. Factors considered:
      
      1. Degree of control the company has over contents of program (selecting content, speakers)
      2. Whether adequate disclosure during the program of sponsorship
      3. Company’s relationship to presenters
      4. Whether unapproved uses will be discussed
      5. Whether the focus of the program is on educational content and free from commercial influence
      6. Whether the audience was selected by company (i.e., reward for high prescribers dispensers or P&T decision makers)
      7. Whether there are promotional activities such as presentations or exhibits in the meeting rooms.

Question 32

Drug Advertising and Promotion

3. Prescription drug advertising:
   a. Advertising Manufacturers to Professionals
   iv. Bad Ad program-

Answer 32

FDA asks health care professionals to assist in recognizing misleading promotional activities and reporting them

Question 33

Drug Advertising and Promotion

3. Prescription drug advertising:
   b. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers

Answer 33

1. Broadcast media:
2. Print advertising
3. Thre categories of Ad
4. Enforcement-FDA scrutinizing ads

Question 34

Drug Advertising and Promotion

3. Prescription drug advertising:
   b. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers
   i. Broadcast media

Answer 34

1. Advertise summary of risks in audio and video form as long as there is an “adequate provision” for the consumer to obtain full labeling information through a multifaceted approach from four sources (suggested to use all four):
   
   1. Toll-free number
   2. Internet web address
   3. Referral to print advertisement in a concurrently running print publication or available brochures
   4. Referral to a health care professional

Question 35

Drug Advertising and Promotion

3. Prescription drug advertising:
   b. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers
   ii. Print Advertising

Answer 35

1. Suggested to list the most serious and common risks associated with the product in consumer user friendly way
   
   1. Modification of approved patient labeling such as package insert or MedGuides OR
   2. Include information contained in highlights section of the package insert

Question 36

Drug Advertising and Promotion

3. Prescription drug advertising:
   b. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers
   iii. Three categories of add:

Answer 36

1. Product claim ads
   
   1. Name the drug and the condition it treats and are subject to regulations
2. Reminder ads
   
   1. Name the drug but not uses; are not subject to regulations
3. Health seeking ads
   
   1. Educational in nature and do not mention name of product only the name of the company
   2. Generally inform the consumer about the disease, mentioning that a physician can treat a particular condition with medications and urge consumer to see physician.
   3. No subject to regulation

Question 37

Drug Advertising and Promotion

3. Prescription drug advertising:
   b. Manufacturer to Consumer (Direct to Consumer DTC) No laws specifically address DTC, consider existing laws and regulations were drafted with the intention of advertising to health care professionals not consumers
   iv. Enforcement- FDA scrutinizes ads

Answer 37

iv. Enforcement- FDA scrutinizes ads

1. FDAAAA allows FDA to require pre-view of DTC ads
   
   1. Limited to providing recommendations to the company
   2. Can require change in an ad if the change addresses serious risks associated with the drug’s use.
2. FDA will look at the “net impression” that the ad conveys from the perspective of a reasonable consumer
3. State courts have significant influence-
   
   1. NJ- manufacturer has legal duty to properly warn of product’s risk

Question 38

Drug Advertising and Promotion

3. Prescription drug advertising:
   c. Promoting prescription drugs for off label use (Area of biggest concern to FDA)

Answer 38

1. Off label- use for indications other than those approved by the FDA, and therefore not included in the labeling.
2. FDAMA (§§ 551 and 552) relaxed FDA policy and allowed companies to provide written information about off label uses under certain circumstances to health care professionals and entities like PBMs, insurance plans, and group health plans.
   
   1. Circumstances permitted: Company must have
      
      1. Filed an application for approval for the use
      2. Submit to the agency, 60 days before dissemination, of a copy of the information to be disseminated and any clinical trial information the company has
      3. Include with the disseminated information, a disclosure that the use has not been approved, a copy of the official labeling of the product, any other products or treatments that have been approved for use, the funding source for any studies relating to the use, and a bibliography of scientific publications regarding the use.
   2. These are not requirements, but merely established the guidelines and actually expired
   3. Current guidance allows companies to distribute unabridged peer review articles published in scientific/medical journals that have not been influence by the company.
      
      1. Should address well controlled clinical investigations considered by experts as scientifically sound.
      2. Should be accompanied by
         
         1. Approved labeling,
         2. comprehensive bibliography of publications regarding the use,
         3. representative publications (if available) that reach contrary or different conclusions,
         4. distributed separately from promotional information,
         5. disclosure that the use has not been approved by FDA
         6. disclosure of any relationship between the company and the article authors
         7. disclosure of any known significant risks or safety concerns not addressed in the article.

Question 39

Drug Advertising and Promotion

4. OTC advertising by manufacturers

Answer 39

1. FTC regulates
2. Prohibits unfair methods of competition and/or deceptive acts or practices
3. No pre-market requirements
4. Largest focus- accuracy of claims
   
   1. Statement or omission of information that is likely to mislead reasonable consumers to their detriment.
      
      1. Advertising claims must have a reasonable and rationale basis
      2. Ex: Listerine ads claiming efficacy of mouthwash against common cold
         
         1. Ingredients not present in sufficient quantity to have therapeutic effect
         2. Impossible to reach critical areas body in significant concentration through normal use (gargling)
         3. Gargling couldn’t reach tissue cells and thus the viruses
         4. Clinical studies were unreliable
         5. The millions of germs killed by mouthwash had no medical significance to cold viruses.
5. Enforcement: cease and desist orders and requirement of companies to issue corrective advertising.
   
   1. Require companies to make affirmative disclosures when necessary to qualify certain statements or to disclose certain adverse consequences of a drug

Question 40

Drug Advertising and Promotion

5. food

Answer 40

5. Food
6. FTC advertising
7. FDA labeling