President Trump recently signed legislation permitting terminally ill patients to obtain experimental drugs directly from manufacturers, without having to wait for full approval.
These same patients cannot use thoroughly evaluated, safe, and effective medicines approved by foreign regulators but not yet by the Food and Drug Administration.
This paradox could be remedied by congressional authorization of drug-approval reciprocity among select foreign counterparts, giving patients rapid access to drugs that have been already proven to work in countries whose testing regimens are similar to our own.
Reciprocal approval would benefit patients directly: the negative effects of FDA delays in approving certain new drugs already available in other industrialized countries are well documented.
Reciprocity would alleviate shortages of critical drugs in the U.S. Many of the drugs in short supply include generic injectable medications commonly used by EMTs and in hospitals: analgesics, cancer drugs, anesthetics, antipsychotics for psychiatric emergencies, and electrolytes needed for patients on IV supplementation.
In a recent court decision, the FDA was blocked from using enforcement discretion to permit the importation of an unapproved drug for capital punishment, because the law is clear that an unapproved drug cannot come through U.S. Customs.
With the Right to Try Act, politicians reaffirmed patient access to investigational drugs, even if these drugs offer only questionable health benefits.
https://www.city-journal.org/html/drug-reciprocity-16082.html
These same patients cannot use thoroughly evaluated, safe, and effective medicines approved by foreign regulators but not yet by the Food and Drug Administration.
This paradox could be remedied by congressional authorization of drug-approval reciprocity among select foreign counterparts, giving patients rapid access to drugs that have been already proven to work in countries whose testing regimens are similar to our own.
Reciprocal approval would benefit patients directly: the negative effects of FDA delays in approving certain new drugs already available in other industrialized countries are well documented.
Reciprocity would alleviate shortages of critical drugs in the U.S. Many of the drugs in short supply include generic injectable medications commonly used by EMTs and in hospitals: analgesics, cancer drugs, anesthetics, antipsychotics for psychiatric emergencies, and electrolytes needed for patients on IV supplementation.
In a recent court decision, the FDA was blocked from using enforcement discretion to permit the importation of an unapproved drug for capital punishment, because the law is clear that an unapproved drug cannot come through U.S. Customs.
With the Right to Try Act, politicians reaffirmed patient access to investigational drugs, even if these drugs offer only questionable health benefits.
https://www.city-journal.org/html/drug-reciprocity-16082.html
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