The order addresses short­ages that affect “can­cer treat­ments . . . and other drugs that are crit­i­cal to the treat­ment and pre­ven­tion of seri­ous dis­eases and life threat­en­ing con­di­tions” that need to be acces­si­ble to health­care providers.

On Octo­ber 31, 2011, Pres­i­dent Obama issued an exec­u­tive order, Reduc­ing Pre­scrip­tion Drug Short­ages. Exec­u­tive orders are pres­i­den­tial reg­u­la­tions that give gov­ern­ment offices or agen­cies admin­is­tra­tive author­ity to inter­pret and imple­ment pro­vi­sions of the con­sti­tu­tion, law, or a treaty.

The order addresses short­ages that affect “can­cer treat­ments . . . and other drugs that are crit­i­cal to the treat­ment and pre­ven­tion of seri­ous dis­eases and life threat­en­ing con­di­tions” that need to be acces­si­ble to health­care providers.

It fur­ther states that cer­tain can­cer treat­ments have “increased by about 20%, with­out a cor­re­spond­ing increase in pro­duc­tion capac­ity,” and that “inter­rup­tions in the sup­plies of these drugs endan­ger patient safety” and limit treat­ment options.

With the force of law, the U.S. Food and Drug Admin­is­tra­tion (FDA) has now been directed “to pre­vent and reduce cur­rent and future dis­rup­tions in the sup­ply of life­sav­ing med­ica­tions.” Specif­i­cally, the order instructs the FDA to

• Work with “man­u­fac­tur­ers to pro­vide ade­quate advance notice” when dis­con­tin­u­ances are imminent.
• “Expand its cur­rent efforts to expe­dite its reg­u­la­tory reviews” over drugs.
• “Com­mu­ni­cate to the Depart­ment of Jus­tice any find­ings that short­ages have led mar­ket par­tic­i­pants to stock­pile” drugs that would cause price gauging.

As the drug short­age issues con­tin­ues to be addressed in the pol­icy arena, ONS will report on the lat­est devel­op­ments. To read the full exec­u­tive order, visit www​.white​house​.gov/​t​h​e​-​p​r​e​s​s​-​o​f​f​i​c​e​/​2​0​1​1​/​1​0​/​3​1​/​e​x​e​c​u​t​i​v​e​-​o​r​d​e​r​-​r​e​d​u​c​i​n​g​-​p​r​e​s​c​r​i​p​t​i​o​n​-​d​r​u​g​-shortages.