Can POTUS make FDA approve a drug (such as hydroxychloroquine), or make it available over the counter? President Trump is known to have taken hydroxychloroquine (HCQ) as a prophylactic against COVID-19. Some prominent medical scientists also came out in support of HCQ for outpatients (as opposed to inpatients, where it's considered ineffective). Yale professor of epidemiology, Dr. Harvey A. Risch stated that he believes that ~100,000 American lives would be saved by HCQ. The FDA initially authorized HCQ for inpatients, but later revoked this authorization. It's currently prescription-only for certain diseases other than COVID-19 (malaria, rheumatoid arthritis, lupus) The issue has been politicized and beset by controversy and fraud. What I'd like to know is if POTUS has the power to compel the FDA to issue an emergency use authorization or to make HCQ available over the counter?
No. Congress, in the Federal Food, Drug and Cosmetic Act, gave the the power to regulate drugs to the FDA, not the President. In addition to giving the FDA jurisdiction, Congress also set up requirements and procedures that the FDA must use to classify and reclassify drugs. (The FDA, acting under the APA and other statutes, has engaged in further procedural rule-making as well.) These procedures require the FDA to hold hearings, etc. before making decisions. Since the President can only execute laws passed by Congress, he cannot bypass the FDA or these procedures. To do so would violate the separation of powers. For example, the FDA could grant its Emergency Use Authorization for HCQ because a statute -- 21 USC § 360bbb-3 Authorization for medical products for use in emergencies -- gives it the power to do so. FWIW, interbranch conflicts over FDA decisions are quite common.
According to an HHS guide entitled "Individuals’ Right under HIPAA to Access their Health Information", HIPAA does entitle you to access your medical records; however, the medical provider has 30 days to respond to your request. See the section on "Timeliness". So if the doctor wants to withhold the information until your appointment in 3 weeks, it looks to me like they are legally entitled to do so. Massachussets law has some similar provisions which are linked from the state court system's page on medical privacy. But as far as I could tell, they also only set a 30 day window, and it only applies to requests that are related to a claim for Social Security or a similar program. It doesn't appear that the law is on your side here. You might have more luck just trying to reschedule your appointment for an earlier date, or letting them know that you would take an appointment on short notice in case they have a cancellation.
The short answer is &quot;yes&quot;. There is U.S. Supreme Court authority that supports this position, In particular, United States v. Laub, 385 U.S. 475 (1967), Cox v. Louisiana, 379 U.S. 599 (1965), and Raley v. Ohio, 360 U.S. 423 (1959), stand for the proposition that a defendant may not be punished for actions taken in good faith reliance upon authoritative assurances that he will not be punished for those actions. If the U.S. Department of Justice (or a U.S. Attorney with jurisdiction over the place the offense was committed) (hereinafter DOJ) says this, people who reasonably rely on that pronouncement can't be prosecuted until a different policy is announced and people who acted in reliance on the previous DOJ position are given a reasonable opportunity to change their conduct in response to the newly announced policy. The statement does have to be a publicly announced policy (or a policy personally communicated to the defendant or his counsel), and not just a de facto reality in terms of prosecutions not being brought in the past, or a secret, unannounced policy (or, for example, an unofficial and offhand statement of the U.S. Attorney General at a party that does not amount to a policy statement). Of course, the defense doesn't protect you if the DOJ says it won't prosecute if you do X, but you do X times Y which goes beyond the safe harbor created by the DOJ pronouncement. For example, the DOJ might say that they will not prosecute conduct involving marijuana offenses that is legal under state law, if it does not violate any other laws, and also meets certain conditions found in federal law (e.g. no offenses within 1000 feet of a school) that the DOJ chooses not to refrain from enforcing. But, if the DOJ then publicly says that it will start enforcing federal law without exceptions on July 1, 2021 and has rescinded its prior policy, a reasonable time in advance, then this defense ceases for conduct after that date. What constitutes reasonable notice would depend upon the facts and circumstances. The DOJ can also reach a binding agreement not to prosecute a particular instance of conduct by a particular person irrevocably in connection with plea bargaining type agreements, with respect to offenses of which the DOJ has jurisdiction (but not necessarily prosecutions by a different government such as a state government or the government of another country, for which the DOJ is not an authorized representative). For example, suppose that a mail carrier is killed by a resident of a home claiming to have acted in self-defense in Denver, Colorado. The DOJ could reach an irrevocable agreement with the resident to accept a plea bargain to a misdemeanor charge of not paying the tax due on the sale of the firearm from a non-compliant gun shop, dismissing forever the charge of murder of a federal post office employee. But that agreement would not bar the District Attorney in Denver from bringing murder charges twenty years later under state law prohibiting murder of human beings in the State of Colorado. For the defendant resident to prevent that from happening definitively, an agreement from the State of Colorado's District Attorney in Denver, or the Colorado Attorney General, would also be required.
All laws (federal, state and local) apply to everybody, unless you have diplomatic immunity. That is, unless e.g. the federal government decides as a matter of policy to ignore certain federal laws. California does not have a law generally prohibiting the use of marijuana, though public consumption is illegal, minor consumption is illegal, and possession over 28.5 grams is illegal. So that is one less law to be concerned with violating. The federal law still exists, and has not been repealed for anyone. However, the federal government by policy is not pursuing marijuana cases in legal contexts in those states that have legalized marijuana. The complication for foreign students is that there are also immigration laws whereby you may be deported for a drug offense (that link is full of technical details on immigration and drug laws, worth reading). The immigration laws basically make it easy to penalize a foreigner (for example you might be deemed "inadmissible" so you cannot be re-admitted to the US if you leave; it just depends on what their grounds are for action). For example, "a noncitizen is inadmissible as of the moment that immigration authorities gain substantial and probative 'reason to believe' the noncitizen has ever participated in drug trafficking," which does not mean a conviction. It is reported that in California, DHS officers have treated minor infractions as "convictions," which means to be safe you have to avoid even infractions. It appears (and hire an immigration attorney if you want to test this) that trouble only arises if there is reason to believe you are trafficking, if you are a drug addict or abuser, if you are "convicted" (not necessarily "tried and found guilty," it also includes certain legal maneuverings), or if you admit to drug use (even in the case of home use under doctor's orders, i.e. a California-legal context). This incidentally includes non-use but working for the marijuana industry. It is possible that you could get stopped on the street by a random immigration search, and if you are in possession, then... it is not guaranteed that possession of a small amount of marijuana, when caught by federal authorities, cannot lead to immigration problems.
Since you asked two questions: No and No Does a company’s T&amp;C or their house rules supersede law No and is asking private health status (including the request to wear a mask) an offence? No A company cannot require you to do things that are against the law but they can require you to do things that go further than the legal minimum. The UK and Spanish governments do not require you to wear a mask but they do not prohibit private organisations (like airlines) for making it a requirement to access their facilities. The law requires that they make reasonable accommodation for people with disabilities. But you don’t have a disability, you just can’t sleep with a mask on. If you had a disability you would have no trouble in getting a letter from your doctor to that effect. The contract requires them to take you from the UK to Spain: they don’t have to enable you to sleep. If you read the T&amp;C, you will find that they can refuse to carry you if, in their reasonable opinion, you pose a hazard to the aircraft or the people aboard it.
A partial answer (for a manufacturer) is "look it up" – that may tell you if a determination has been made by the FDA. If so, it is not new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product (the FDA says). The legal part doesn't explain how it is scientifically determine that an inactive ingredient raises safety concerns but to take on example, wheat gluten is in the Inactive Ingredient Guide. This article gives a bit of analysis of the factors that sponsors have to consider in shouldering their burden of proof. If you want to manufacture a new vaccine, you have to show (the FDA) that it is safe. If you dilute the vaccine with water, that ingredient is not a "safety factor". Benzalkonium chloride could be (you would have to show that it isn't), and if it is, that regulation requires you to list it. What's not specified clearly is how many adverse reactions per million doses constitute being a safety factor.
The doctor is a professional Engineers don’t put extra wings on airplanes because the client asks. Lawyers don’t throw unsubstantiated allegations in their pleadings because the client asks. Accountants don’t change the balance sheet because the client asks. And doctors don’t prescribe unnecessary medications or vitamins because the client asks. For most people with normal health and a relatively balanced diet, nutritional supplements are medically unnecessary. They may make the user feel better through the placebo affect but doctors prescribe things that are necessary, not things the patient wants but doesn’t need. You can sue a doctor if they are negligent. One sure sign of negligence is if they adopt the treatment plan proposed by the patient without applying their professional judgement.
House Rule XI(m), p. 19, states the power of committees and subcommittees to issue subpoenas. (1)…a committee or sub-committee is authorized (subject to subparagraph (3)(A)) …to require, by subpoena or otherwise, the attendance and testimony of such witnesses… (3)(A)(i) Except as provided in sub-division (A)(ii), a subpoena may be authorized and issued by a committee or subcommittee under subparagraph (1)(B) in the conduct of an investigation or series of investigations or activities only when authorized by the committee or subcommittee, a majority being present. A subcommittee could therefore authorize the chair of the subcommittee to issue subpoenas with no vote at all. Otherwise, the (sub)committee must "authorize" a subpoena, which conventionally means "vote on the motion". There is no requirement that the entire house must vote on subpoenas. There is no question that POTUS did not obey the demand of the House subcommittee. The argument that will most likely be proffered is not that the House violated its rules, but that the House rules exceed constitutional authority in issuing the subpoena. As pointed out in this analysis, this is not a well-established and settled question of constitutional law. There is no rule that requires a full House vote on all subcommittee rules established by a subcommittee that forwards articles of impeachment to the full House. That is, a subcommittee does not have to get prior approval of the full House in order for a subcommittee to conduct business and recommend an action to the full house. Instead, the House simply votes yes or no on the particular articles, following the rules for House votes.