Food & Drug Outline – 2010 – Collier
v Intro and Background
o Course Themes
§ FDA legislation is frequently crisis driven (rather than the product of a reflective deliberative process), thereby allowing Congress to be perceived as “doing something”
§ The FDA has differing powers/remedies depending upon the type of product (food, drug, device)
§ Congress is always willing to add new responsibilities to the FDA’s regulatory mandate w/o necessarily funding the performance of the same
· Congress can then blame regulatory agencies for not acting to the fullest extent of their statutory authority, but the reason is that the agencies don’t have sufficient funding
§ FDA moving from policing à gatekeeper
§ Hard for FDA to act
· Must discover violations
· FDA and regulated entity usually both prefer resolving the issue informally
· If FDA decides to impose sanctions – must abide by formal procedures (time consuming)
o Pharmaceutical/Biotech industries
o Regulatory “players”
§ FDA – FIRST CITIZEN PROTECTION AGENCY OF THE GOVT (model adopted by others…)
§ FTC: jur over consumer protection and ATR issues
§ Medicare/Medicaid – govt is now a payer of medications
§ HHS – FDA is part of HHS
§ State agencies
§ USDA – roots of FDA are in USDA
§ Center for Disease Control
§ SEC – disclosure obligations (e.g., tell shareholders trial results – Martha Stewart case)
§ PTO
§ Lobbyists
§ Citizen/Consumer Groups – try to help orphan groups, file citizen petitions
o Current Landscape/Issues
o Access to Unapproved Products
§ Abigail Alliance for Better Access to Dev’t Drugs v. von Eschenbach
· Facts: Alliance wants court to stop FDA from barring sale of new drugs already det’d sufficiently safe for expanded human testing (Phase 1)
· Procedural: citizen petition
· Issue: Whether the Due Process Clause protects the right of terminally ill patients to decide, without FDA intervention, whether to assume the risks of using potentially life-saving investigational new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase 1 clinical human trials, are safe enough for further testing on a substantial number of human beings.
· Disp: remanded to determine whether FDA’s policy is sufficiently narrowly tailored to serve a compelling govt interest
§ FDA allows individuals to import 3 mos of an unapproved new drug for personal use in 2 circs:
· The intended use is appropriately identified and is not for the treatment of a serious condition, and the product is not known to be a serious threat to health OR
· The intended use is unapproved and for a serious condition for which treatment may not be available domestically, there is no known commercialization or promotion to persons residing in the US by those involved in the distribution of the product, the product does not represent and unreasonable risk, and the individual seeking to import the product provides the name of a doctor responsible for treatment in the US or provides evidence that the product is for continuation of a treatment begun abroad
§ Suthers v. Amgen
· Facts: Parkinsons patient participated in research trial that req’d surgery to implant a pump in abdomen and catheters into the brain – got placebos for 6 mos, then treatment
o Patient tried to show promissory estoppels, duty, etc.
· Issue: whether Amgen must continue to provide medication provided during a clinical trial to participants who believe they benefited from the treatment
· Disp: No
· Holding: No duty to continue to provide medical treatment offered during a clinical trial
· Reasoning: no meeting of the minds req’d for a contract claim
v Origins and Organizational Structure of FDA/Oversight of the Drug Regulatory Process
o Legislative Stakes
§ Import Drug Act of 1848
· Situation: very bad conditions, citizens getting sick, no purpose for many drugs, very little regulation (mostly state or local)
o Federal interests = protect commerce, even at the expense of consumers
· Effect: Banned adulterated foods and meds from abroad
· Missing: Did NOT address the domestic problem
§ Biologics Act of 1902
· Situation: born of tragedy in 1901, muckracking journalists (Upton Sinclair)
· Effect:
o introduced concept of pre-market approval,
o req’d a product license and an establishment license,
o allowed for inspection of private manufacturing premises (big deal!)
§ usually govt can’t go onto private property without probable cause/warrant, etc.; US govt can even inspect foreign facilities that product drugs for consumption in US; company can’t turn govt away or say they have an emergency situation
· Missing: limited to biologics, did NOT apply to drugs
§ Pure Food and Drugs Act of 1906
· Situation: weaker than Biologics Act, biz still trumping individual’s interests
· Effect: (1st federal statute to address standards for prep and marketing of drugs)
o created 1st regulatory agency to be responsible for food and drug,
o drugs can’t be adulterated or impure,
o foods can’t be adulterated or misbranded/falsely labeled,
o Introduced words of art – e.g., “adulteration” and “misbranding”
o Allowed for seizure/criminal prosecution – but no additional money
§ FDA given role of “beat-cop” (VERY difficult and $$$$!)
§ Really heaven burden for govt to prove, no real money to implement
· Missing:
o didn’t actually require labeling, just that if you made a statement, it had to be true (get around by saying nothing and then making claims in ancillary media),
o still just about after the fact policing (no pre-market action)
§ Federal Food, Drug and Cosmetic Act of 1938
· Situation: born of tragedy (windshield wiper fluid mixed into kids drug), time of depression – other priorities, superseded/replaced 1906 law, scientific proof starting to prevail over commercial interests/anecdotal evidence
· Effect:
o Regulated additional products –
§ devices
§ cosmetics
o Introduced concept of pre-market screening for the safety of drugs (manufacturers must prove safety in order to sell drug)
§ 505(a): No person shall introduce or deliver for introduction into interstate commerce any NEW DRUG, UNLESS an approval of an application filed pursuant to (b) or (j) is effective w/respect to such drug
· Req’d research by manufacturers to create safety package
o Made patents more important
o “new drug” = any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof
§ Sec 301 (21 USC 331) PROHIBITED ACTS The following acts and the causing thereof are hereby prohibited: (d) the introduction or delivery for introduction into interstate commerce of any article in violation of section 505
o Added additional remedies –
§ Rulemaking: FDA no longer needs to run from D-to-D
§ 304(a) SEIZURE:
k, affronting law through means is fine?)
· FDA has a lot of ammunition/powers, while the regulated community has few (litigation, lobbying, testimony at hearings, citizen’s petition – most effective bc FDA must respond)
o FDA adjudicatory procedures
§ Remedies available to the FDA (depends on product)
· SEIZURE – w/o a pre-deprivation hearing (no due process issue), they can seize and explain later
o 304(a) – seizure = any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or which may not, under the provisions of 404 or 505, be introduced into interstate commerce, shall be liable to be proceeded against… on libel of info and condemned in any district court… w/in the jurisdiction of which article is found
o Missing: only about SAFETY, nothing yet about efficacy; could sell unless govt said you
o FDA may seize violative products, then manufacturer may appear in condemnation proceeding as a claimant in order to challenge the FDA’s action (but the manufacturer may NOT ask a court to enjoin those proceedings)
o US v. Alcon Labs
§ Facts: Alcon manufacturing WANS (Drug), sold in 3 strengths (1, 2, kid), FDA wanted drug to go through NDA to be sold to children, Alcon said no, FDA seized drug
§ Issue: whether FDA could seize “new drug” marketed without approval through NDA process?
§ Disp: Yes – seizure permissible
§ Holding: FDA is not required to make a showing on the merits at the time of seizure (no need for probable cause – seize now, explain later)
§ Reasoning:
· Alcon wants to show WANS is NOT a new drug, or if new, must prove safety and efficacy
· INJUNCTION
o Sec 302(a) INJUNCTION PROCEEDINGS: dist cts shall have jurisdiction to restrain violations of sections 301, except paragraphs (h), (i), and (j)
o Pro: can deal with recurring infractions instead of constantly returning to court or seizing
o Con: must go to court to get this
o Burden: FDA need NOT show irreparable harm or the inadequacy of remedies at law in order to receive such equitable relief; FDA need only show a reasonable likelihood that identified violations of the statute would otherwise continue
o The following methods of injunctive relief aren’t as controversial anymore
o SIMPLE INJUNCTION
§ Can’t sell product anymore, no more advertising, etc.
o RECALL
§ Injunction power does NOT give FDA authority to order a drug recall (there is power to recall medical devices, baby formula, etc.)
§ Effect: usually FDA will threaten to seize, the companies will announce a voluntary recall
§ US v. Superpharm Corp (1981)
· Facts: FDA says Superpharm engaged in manufacture and distribution of human drug w/o approval
· Issue: whether FDA has authority to order drug recall
· Disp: No
Holding: FDA cannot order drug recall, it may ask a company
