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SOCMA Pushes for Removal of Pharmaceuticals From Section 301 Tariff List

The Society of Chemical Manufacturers and Affiliates asked that "the pharmaceuticals and chemicals used to make pharmaceuticals" be removed from the Office of the U.S. Trade Representative's list of goods from China that will be subjected to new Section 301 tariffs. That request came in rebuttal comments to the USTR filed after three days of International Trade Commission hearings on the proposed list of goods subject to Section 301 tariffs (see 1805170042). Specifically, all the Harmonized Tariff Schedule subheadings from 2914.62.00 to 3006.30.10 should be removed, SOCMA said.

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China is the sole source for many active pharmaceutical ingredients used in over-the-counter drug products, SOCMA explained in previously filed comments. "While APIs present a major cost factor for all generic medicines, they are by no means the only cost driver," the group said. "Excipients, binders, coatings and a variety of other specialty and fine chemicals are needed as starting materials in pharmaceutical manufacturing processes. Tariffs on these chemicals will only add to cost factors and will force increases in prescription and OTC retail drug prices. Also, tariffs on regulatory starting materials and reagents will drive up costs for U.S. API manufacturers."

The American Association of Orthopaedic Surgeons said in its post-hearing comments that the Section 301 tariffs shouldn't apply to medical technologies. "Many of the medical devices included in the USTR 301 list directly impact orthopaedics," the group said. " Artificial joints, orthopaedic and fracture appliances, needles, sutures and surgical instruments used by our surgeons appear on the Section 301 list." Also affected would be the "radiation therapy, ultrasound, x‐ray and other medical technologies that affect our orthopaedic patients."

Novast Laboratories, which "developed and manufactured generic oral contraceptives" classified in subheading 3006.60.00, said the proposed tariffs "directly threaten our ability to supply birth control to millions of American women." Novast's products account for 10 percent to 15 percent of the U.S. oral contraceptive market and "there is a high risk that the proposed Section 301 tariffs will create a shortage of supply of oral contraceptives for at least for some period of time," the company said in its comments. The inclusion of birth control on the list also "disproportionately targets women over men to a degree that is unprecedented compared to the other products on the list."

Vancomycin hydrocholoride and coartem tablets should be excluded from the Section 301 list, Zhejiang Medicine said in its comments. There are only two U.S. producers of vancomycin hydrochloride, used to treat methicillin-resistant staphylococcus aureus, and one recently underwent a recall of the antibiotic due to contamination, the company said. Zhejiang subsidiary Novus is the only producer of coartem tablets, used to treat acute malaria infections, approved by the Food and Drug Administration, it said. The U.S. military buys a million tablets per year, so "an increase in the price of coartem caused by the Section 301 would be either absorbed by the military or result in shortages for the troops," it said.